Industry Spotlight


Outset Medical, based in San Jose, CA, went public on the Nasdaq exchange on Sept. 17, 2020, with a $241.7 million initial public offering (IPO). The IPO made quite a splash on the market. Nasdaq tweeted: “OM [Nasdaq trading symbol for Outset Medical] has the highest raise in 2020 of healthcare equipment and technology companies.”

Two recent studies show promise for people with type 2 diabetes with kidney disease.

Bayer announced that results of the phase 3 FIDELIO-DKD study of the drug finerenone met its primary endpoint of delaying progression of chronic kidney disease (CKD) in type 2 diabetes patients. CKD progression was delayed through reduction of the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) greater than or equal to 40% from baseline over a period of at least four weeks, or renal death.

The US Food and Drug Administration (FDA) has agreed once again to review a kidney cancer drug for approval, and noteworthy results from a phase 3 trial of a different drug for kidney cancer may yield further exploration.

Aveo Pharmaceuticals (Cambridge, MA) filed a New Drug Application (NDA) with the FDA. Aveo is seeking approval for tivozanib (brand name Fotivda), a vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) to treat relapsed or refractory renal cell carcinoma (RCC). The drug was approved for the European market in 2017.

DaVita (Denver, CO) has contributed an undisclosed amount to a round of funding for Wellth, a new company that uses behavioral economics principles to improve chronic-disease patient compliance with treatments in many areas of health. DaVita and Rock Health were the two new contributing members to the total of $10 million that Wellth, based in Los Angeles, raised recently. Top contributors include Boehringer Ingelheim Venture Fund and yabeo, a German investment firm that supports “young, innovative companies.”

A new trial with the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin (brand name Farxiga) is recruiting COVID-19 patients with type 2 diabetes and other conditions to assess whether the drug can reduce COVID-19 progression.

However, the 900-patient, placebo-controlled DARE-19 trial (Dapagliflozin in Respiratory Failure in Patients with COVID-19) with the drug is proving controversial.

Cricket Health, a company that aims to provide cost-effective integrated nephrology and dialysis, has begun to leverage its high-tech approach to kidney care by helping major insurer Cigna identify patients who may need further care./kidneynews/12_5/26a/graphic/26af1.jpg

The US Food and Drug Administration cleared Outset Medical’s Tablo device for home dialysis in March. It was previously cleared for in-center and hospital use.

The US Food and Drug Administration (FDA) recently approved the first pill to combine three type 2 diabetes medications: Trijardy XR (extended release). The triple-combination pill is marketed through a partnership of Boehringer Ingelheim and Eli Lilly and includes the following medications:

Two companies recently announced clinical trials for promising drug candidates for kidney diseases.

Goldfinch Bio (Cambridge, MA) is entering into an agreement with Osaka, Japan–based Takeda to develop a drug to treat rare and metabolic kidney diseases. The agreement will grant Takeda worldwide rights to the cannabinoid receptor 1 (CB1) monoclonal antibody, which inhibits CB1. Goldfinch says terms are not being disclosed.

In the spring of 2020, nephrologist Reshma Kewalramani, MD, FASN, will assume the mantle of president and CEO of Vertex (Boston), a biotechnology company with revenues of $3.04 billion for fiscal year 2018. She will move up from her current position as executive vice president for global medicines development and medical affairs and chief medical officer at the company.


New reports on the markets for vascular grafts, including hemodialysis grafts, provide insights into this growing industry.

A week after President Donald J. Trump signed an executive order directing improvement in diagnosis and treatment of patients with kidney diseases and emphasizing increased use of home dialysis, CVS Health announced the start of a clinical trial into the safety and efficacy of a new home system, the HemoCare Hemodialysis System.

The trial is expected to enroll 70 patients at 10 U.S. sites.

Remote dialysis monitoring services are vying for new customers, as dialysis usage in differing settings continues to grow, spurred by the recent U.S. executive order under the Advancing American Kidney Health initiative, which aims to encourage home-based dialysis./kidneynews/11_9/11/graphic/11f1.jpg

The U.S. Food and Drug Administration (FDA) has given type 2 diabetes drug Farxiga (dapagliflozin) a fast track designation that aims to help chronic kidney disease (CKD) patients. AstraZeneca (Cambridge, UK) announced that the drug was fast tracked for development as a treatment to delay the progression of kidney failure and prevent cardiovascular and renal death in patients with CKD.

Several clinical trials presented at the American Diabetes Association meeting in June 2019 show promise in terms of improved renal function in type 2 diabetes patients.


Although its drug for use in patients with autosomal dominant polycystic kidney disease (ADPKD) is still pending FDA approval, Reata (Irving, TX) recently won orphan drug designation for the candidate drug, bardoxolone methyl, according to Zacks Equity Research.

Rockwell Medical, Inc. (Wixom, MI) announced that the United States has approved commercial sales of Dialysate Triferic.

The company is developing multiple formulations of Triferic for treating anemia in adult hemodialysis patients. Dialysate Triferic is the first formulation to be sold. Rockwell expects to file a New Drug Application (NDA) with the FDA for its next formulation, I.V. Triferic, within the second quarter of 2019, the company said in a media release.

Simergent announced plans to use a new round of seed money, $2.835 million, to further development of a cheaper, quieter home dialysis machine. The company, with offices in Oklahoma City and Chicago, said in a media release that its Archimedes dialysis system “aims to reduce healthcare expenditures, improve patient health, and make it easier for patients to perform dialysis at home.”

Kent Thiry has resigned as chairman and chief executive officer of DaVita (Denver, CO), one of the largest kidney care services companies in the world. After 20 years in the role, the colorful CEO was practically synonymous with the company.

MarketWatch reports that he will transition to executive chairman of DaVita. Javier Rodriguez takes over as CEO of the company (after serving as CEO of DaVita Kidney Care).

News concerning combination drugs in the kidney cancer space continues apace. Recently, Merck & Co. and Pfizer obtained approval from the US Food and Drug Administration (FDA) for a combination of Merck’s Keytruda (pembrolizumab) and Pfizer’s Inlyta (axitinib) as a frontline treatment for patients with advanced renal cell carcinoma.

The US Food and Drug Administration (FDA) has approved a new stent for use in the treatment of kidney failure patients who are on hemodialysis.

Abbott Laboratories (Chicago, IL) currently leads the market in pain-free glucose monitoring, Crain’s Chicago Business reports. Abbott offers the FreeStyle Libre, which measures glucose via a sensor without fingersticks. According to Crain’s, Abbott’s device has more than 1.3 million users worldwide and posted 37% sales growth to $1.9 billion in 2018.

Rural dialysis does not pay as well as dialysis in urban facilities, according to a recent report from the Medicare Payment Advisory Commission (MedPAC).

The March 2019 report noted that facilities with high volumes of dialysis earned higher margins because cost per treatment falls with efficiencies, and that urban facilities had higher financial margins (-0.4%) than do rural facilities (–5.5%).


Roche and IBM have teamed up to parse half a million electronic health records (EHRs) to create a predictive algorithm for patients with early risk of chronic kidney disease (CKD) related to diabetes. The industry duo developed the algorithm based on real-world data.

The world is one step closer to a dialysis device that can be readily carried by a patient, while another company is working to create an ultra-thin blood filter for a wearable dialysis device.

The US FDA has granted a Breakthrough Device designation to AWAK Technologies (Singapore) for a new peritoneal dialysis (PD) device, the AWAK PD.

AstraZeneca (Cambridge, UK) is emphasizing its dedication to chronic kidney disease (CKD) and related conditions. In a sign of its focus on the “R” in its renamed division, Cardiovascular, Renal, and Metabolism (CVRM), the company offered research and information in 35 separate scientific articles and data presentations during Kidney Week 2018.

HealthCare Partners Holdings LLC, part of DaVita Inc., must pay $270 million to settle an allegation involving Medicare Advantage insurance plans.

According to a news release from the U.S. Department of Justice, DaVita Medical Holdings agreed to pay the money to resolve its liability under the False Claims Act. The Justice Department reported that HealthCare Partners provided “inaccurate information that caused Medicare Advantage Plans to receive inflated Medicare payments.”

Two companies have been given the thumbs-up by the U.S. Food and Drug Administration (FDA) for kidney-related therapies. Hansa Medical (Lund, Sweden) has been granted FDA Fast Track Designation for its drug candidate imlifidase to help reduce kidney rejection in transplantation. Under this designation, the FDA process is designed to facilitate development and expedite the review of drugs that could treat serious conditions and fill an unmet medical need. Another company, MediBeacon Inc. (St.

A new study called FirstX is now enrolling participants and will examine a compound called CXA-10 in primary FSGS as a first-line drug for people who would normally have been treated with high-dose steroids. CXA-10 is in a class of oral compounds called nitrated fatty acids. It is a signaling agent with anti-inflammatory/immunomodulatory, antifibrotic, antioxidative, and other properties that are important in the pathobiology of FSGS, according to an abstract for the trial presented during ASN Kidney Week 2018.

Reata Pharmaceuticals (Irving, TX) has received a $30 million milestone payment from its licensee, Kyowa Hakko Kirin as part of a corporate agreement.

In 2017, Kyowa Hakko Kirin reported positive results from the phase 2 TSUBAKI trial of bardoxolone methyl (bardoxolone) in patients with type 2 diabetes and chronic kidney disease. Initiation of the AYAME phase 3 clinical trial to assess the efficacy and safety of bardoxolone for the treatment of diabetic kidney disease in Japan was the trigger for the payment.

Outset Medical (San Jose, CA) recently completed another round of financing, raising $132 million in Series D equity financing to help accelerate production and commercial expansion of the Tablo Hemodialysis System.

The lead investor in this round of financing was Mubadala Investment Company of Abu Dhabi. Other participating investors in Outset Medical, which launched in 2010, include Baxter Ventures, Fidelity Research and Management, and Warburg Pincus, an early investor.

Dialyze Direct, LLC, a leading provider of staff-assisted home hemodialysis services in skilled nursing facilities with geriatric populations, has signed an agreement to acquire Affiliated Dialysis Centers, LLC, an established dialysis provider with corporate headquarters in Glen Ellyn, IL.

An independent regional provider of dialysis services serving more than 400 patients in Illinois and Ohio, Affiliated Dialysis Centers will effectively double its current patient count under the purchase agreement with Dialyze Direct, said Dialyze Direct CEO Josh Rothenberg.

As more consumers eschew plastic straws and water bottles, the dialysis manufacturing sector is taking a closer look at the possibilities of reusing resources used in dialysis, including water and plastic. Water is also being analyzed as a commodity that could be used more sparingly throughout dialysis.

The Committee for Medicinal Products for Human Use in the European Union recommended denial of a change to the marketing authorizations already in place for the drugs Opdivo (nivolumab) and Yervoy (ipilimumab), according to the European Medicines Agency.

Bristol-Myers Squibb (New York, NY) asked the committee to consider authorizing marketing for use of both drugs in combination to treat patients with untreated, advanced renal cell carcinoma., based in Tel Aviv, Israel, has obtained U.S. Food and Drug Administration (FDA) marketing clearance for its first digital dipstick kit offering. The is advertised on the company’s website as having the accuracy of “the standard lab-based urinalysis analyzer.”

The dipstick is being marketed in Europe and is certified by CE and International Organization for Standardization (ISO) 13485 for sale in the European Union. The urinalysis dipstick includes 10 determinations, including indicators for possible CKD, on the strip.

Otsuka Pharmaceutical (Tokyo) has signed a merger agreement to acquire the clinical-stage biotechnology company Visterra (Waltham, MA) for about $430 million in cash.

The U.S. Food and Drug Administration (FDA) has granted marketing approval for two catheter devices used in dialysis. Both the everlinQ endoAVF System, which uses two catheters, and the Ellipsys Vascular Access System with a single catheter are designed to create arteriovenous (AV) fistulas, using an energy source to forge the connection between blood vessels in a patient’s arm. Traditionally a central venous catheter for dialysis patients is created through a surgical process. An AV graft uses a tube or cadaveric blood vessel to create a bridge between artery and vein.

Manufacturers of two different diabetes drugs have reported positive results recently.

Jardiance (empagliflozin) consistently reduced the risk of new or worsening kidney disease versus placebo, reported a two-member diabetes pharmaceutical alliance.

Boehringer Ingelheim (Ridgefield, CT) and Eli Lilly (Indianapolis) joined forces in 2011 to form an alliance that centers on compounds in “several of the largest diabetes treatment classes,” the companies noted.

XORTX Therapeutics, a company founded to focus on developing therapies to treat progressive kidney disease, has filed a pre-IND (Investigational New Drug) meeting request with the FDA. The company, based in Calgary, Alberta, filed pre-IND documents and secured a September 2018 meeting with the FDA to discuss development of its compound, XRx-008, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The company currently plans to advance XRx-008 through phase 2 clinical trials.

A new company is forming to produce treatments for patients with chronic kidney disease (CKD). Subject to antitrust considerations, the merger of Akebia Therapeutics (Cambridge, MA) and Keryx Biopharmaceuticals (Boston, MA) is expected to be complete by the end of the year. The new company will be called Akebia Therapeutics.

The merger is valued at $1.3 billion, notes Pitchbook, a financial newsletter. Under terms of the merger, Akebia shareholders will own a bit more than half of the combined firm, the website FierceBiotech reported.

The U.S. Food and Drug Administration recently approved Pfizer’s biosimilar anemia drug, Retacrit (epoetin alfa-epbx). After two previous approval attempts, Retacrit was approved as a biosimilar to Epogen (Amgen) and Procrit (epoetin alfa, Johnson & Johnson).

Baxter International, in Deerfield, IL, has released data from two independent studies that explored expanded hemodialysis therapy (HDx) with its Theranova™ dialyzer. Expanded hemodialysis refers to applying high retention-onset membranes able to filter out molecules in the mid- to high molecular weight range.

Tricida, a privately held company based in South San Francisco, announced positive results from its most recent trial, a Phase 3 study of TCRA-301 to examine the drug’s effects on metabolic acidosis in patients with chronic kidney disease (CKD). Tricida also filed for $150 million in an initial public offering to fund kidney drug approval.

RenalGuard Solutions has announced results for an additional patient population with a form of heart failure. The Milford, MA, company demonstrated the ability of RenalGuard-Guided Diuretic Therapy to control and optimize fluid management in patients with acute decompensated heart failure. Heart failure is common in patients with CKD and end stage renal failure.

RenalGuard measures urine output and automatically infuses saline (hydration fluid) according to the ideal present fluid loss limits set by the physician.


In mid-April 2018, Puerto Rico again experienced a total blackout, this time because of an electrical subcontractor’s mistake, not an act of nature like Hurricane Maria, which devastated the island in September 2017.

Fresenius Medical Care North America (FMCNA, Waltham, MA), has launched a foundation to create awareness and a national dialog about chronic kidney disease (CKD) and transplantation.

The funding will come from FMCNA employees and medical staff and other individuals, with FMCNA pledging to match up to $1 million of contributions during the first year.

Otsuka Pharmaceutical’s drug Jynarque (tolvaptan) received US Food and Drug Administration (FDA) approval as the first drug treatment in the United States to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The drug is a selective vasopressin V2-receptor antagonist.

Pharmacy giant CVS (Woonsocket, RI) recently announced that it will enter the kidney care market. The company will take a stepwise approach in a new initiative that will focus on chronic kidney disease and home-based dialysis.

The company’s first focus will be on patient education and early detection of kidney disease. It also plans to introduce a new home hemodialysis technology designed to make home hemodialysis simple and safe for patients, and to facilitate longer and more frequent treatments.


Two manufacturers reported on recent results in acute kidney injury (AKI) studies.

Merck & Co., in Kenilworth, NJ, and Tokyo-based Eisai Co. Ltd. signed a collaboration to develop and sell Eisai’s renal cancer drug Lenvima (lenvatinib), a tyrosine kinase inhibitor.

The drug is already approved in many countries for advanced renal cancer and for locally recurrent or metastatic differentiated thyroid cancer.

The terms specify that Lenvima will be developed for several types of cancer as a standalone treatment and in combination with Merck’s anti–PD-1 immunotherapeutic agent, Keytruda (pembrolizumab).

DaVita has cut 38 positions in a clinical research arm of the company based in Minneapolis. The cuts are “part of a company decision to discontinue one of three segments in its clinical research division,” a spokesman said in an e-mail to the Minneapolis Star Tribune.

The company will be discontinuing its work in “early clinical research” in Minneapolis and also in Denver, according to the Star Tribune.

Dialysis companies have found themselves settling lawsuits recently. Fresenius Medical Care North America (FMCNA) disclosed breaches of protected electronic health information and settled with a federal agency, while American Renal Associates (ARA), without admitting wrongdoing, settled with shareholders.

In early February 2018, FMCNA, a major dialysis provider, settled with the Department of Health and Human Services Office of Civil Rights (OCR).

Two companies are offering products that use artificial intelligence (AI) to help improve kidney conditions.

RenalGuard Solutions (Milford, MA) said in 2017 that it expected a premarket approval filing for its fluid-management device in 2018, based on its contrast-induced nephropathy (CIN) study, CIN-RG, which is currently enrolling subjects.

The company’s investigational device, RenalGuard, protects patients from acute kidney injury (AKI), including contrast-induced AKI (CI-AKI). The system was designed to rapidly remove contrast dyes that can be toxic to kidneys.

Flying Brands, based in Jersey, United Kingdom, announced that it has received a CE (Conformité Européene) mark approving its Stone Checker software for use in the European Union and some affiliated nations in Europe. The CE seal confirms that a product meets the essential requirements of relevant European health, safety, and environmental protection legislation.

Flying Brands is an investment company that focuses on opportunities in the technology and logistics sectors, and Stone Checker Software Ltd, is part of Flying Brands.

In mid-December, the U.S. Food and Drug Administration announced it had approved Sanofi-Aventis US’s (Bridgewater Township, NJ) Admelog (insulin lispro injection), a short-acting insulin indicated to improve control of blood glucose levels in adults and pediatric patients 3 years and older with type 1 diabetes and adults with type 2 diabetes. Admelog is the first short-acting insulin approved as a “follow-on” product [submitted through the agency’s 505(b)(2) pathway, a shortened route based on comparative evidence with an approved drug].

A recent, albeit early, study found that a combination of two Genentech drugs, Tecentriq (atezolizumab) and Avastin (bevacizumab), reduced the risk of disease worsening or death as an initial treatment in some individuals with advanced kidney cancer. Genentech is a division of Roche, and is headquartered in South San Francisco, CA.

In early December, UnitedHealth and Denver-based DaVita announced that UnitedHealth would spend $4.9 billion to acquire DaVita Medical Group, comprising a medical staff of about 2000 physicians in a group currently owned by one of the nation’s largest dialysis companies. United Health Group’s Optum segment has headquarters in Eden Prairie, MN, and has clinics or centers in more than 150 locations worldwide.

Two companies with products that reduce the amount of contrast dye in a patient’s system are raising money to increase sales and to support critical research. Contrast dye used in vascular and other imaging may cause such complications as acute kidney injury (AKI) in kidney-impaired patients.

B. Braun (Melsungen, Germany; US base, Bethlehem, PA), a manufacturer of dialysis equipment and disposables and other medical products, has launched a new dialyzer called the Diacap Pro. The filter device, which received FDA approval in late August 2017, uses a new type of fiber designed to improve dialysis dose.

The Diacap Pro fibers clear blood toxins like urea and creatinine, while retaining molecules like albumin, and comes in three sizes (1.3 m2, 1.6 m2, and 1.9 m2) to address differing patient needs.

Bristol-Myers Squibb (New York, NY) announced in early September 2017 a successful phase 3 study of a combination therapy to improve overall survival in kidney cancer.

The company tested a combination of its drugs Opdivo (nivolumab) and Yervoy (ipilimumab), which demonstrated better overall survival rates than a standard-of-care drug (Pfizer’s SUTENT (sunitinib malate) in previously untreated patients with advanced or metatstatic renal cell carcinoma.

Fresenius Medical Care (FMC), the world’s largest provider of dialysis products and services, will buy NxStage, a home dialysis device maker, for $2 billion. Fresenius Medical Care North America and NxStage both have corporate headquarters in the Boston area, while FMC parent company is based in Bad Homburg, Germany.

The NxStage System One is cleared by the FDA for home hemodialysis and home nocturnal hemodialysis. NxStage has also established a small number of dialysis clinics.


American Renal Associates Holdings (ARA) (Beverly, MA) launched an initial public offering in April 2016, and has now grown to 217 clinics serving more than 15,000 patients with 385 nephrologists.

For the second time in 2017, Pfizer has received a disappointing letter about its progress toward FDA approval for a biosimilar product similar to the drug Epogen. The root of the problem lies with manufacturing facilities that may produce the biosimilar, not with the safety or biosimilarity to Epogen, Pfizer notes.

A new program sponsored by a company that develops technology-based solutions for chronic kidney disease (CKD) will give 100 patients access to new formats for care and education.

New research shows that an existing type 2 diabetes drug also significantly decreases the risk of other serious conditions. A study published in the New England Journal of Medicine demonstrated that the drug canagliflozin, in addition to helping to treat 2 diabetes, also seems to significantly lower the risk of cardiovascular disease (CVD) and kidney disease in patients with diabetes, Reuters reported.

Now that positive results from Phase 3 clinical trials have been reported, the European Medicines Agency (EMA) has recommended approval for tivozanib through the EMA’s Committee for Medicinal Products for Human Use (CHMP), as treatment for advanced renal cell carcinoma (RCC). The drug, brand named Fotivda (AVEO Pharmaceuticals, Cambridge, MA) could receive a final decision for approval by late August or early September 2017. The US Food and Drug Administration approved the drug in 2013.

Baxter International (Deerfield, IL) is developing a system to produce sterile solutions for peritoneal dialysis (PD) in patients’ homes. The company said it received FDA guidance about the regulatory pathway for the system, which would be integrated into Baxter’s Amia PD System with a small water-filtration device.

Vifor Pharma, a global specialty pharmaceuticals company in Zurich, Switzerland, that develops its own products and also partners with other companies, in May 2017 agreed to invest in and sell Akebia Therapeutics’ Phase 3 anemia drug vadadustat through its network of dialysis centers. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer in development for treatment of anemia associated with chronic kidney disease (CKD).

A new rapid, noninvasive test that can detect infections among peritoneal dialysis (PD) patients has earned the “Conformité Européene” (CE) mark. This mark means that a product may be marketed within the European Economic Area.

The regulatory submissions are supported by positive results from a Phase 3 S-TRAC, (Sunitinib Trial in Adjuvant Renal Cancer) study.

Pfizer Inc. announced that the FDA and the European Medicines Agency (EMA) accepted the company’s regulatory submission for label expansion of its renal cell carcinoma (RCC) drug, Sutent (sunitinib). The FDA’s response is expected in January 2018.

One year after US Food and Drug Administration (FDA) approval of Rayaldee (calcifediol), Miami-based OPKO Health in June 2017 announced new agreements for the drug with several large Medicare Part D (prescription drug coverage) plan sponsors. The drug helps treat secondary hyperparathyroidism (SHPT) in patients with stages 3–4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D less than 30 ng/mL.

For the first quarter of 2017, the dialysis business for Fresenius Medical Care North America (FMCNA) grew by 14% (10% at constant currency). Quarterly growth was influenced by the positive effect of an agreement with the US Departments of Veterans Affairs (VA) and Justice for a settlement for underpayment, a favorable impact from commercial payers, and an increased number of treatments. Dialysis care revenue for the quarter rose to $2.65 billion from $2.32 billion from the first quarter of 2017 to the first quarter of 2016.


A quietly flourishing sector of the hemodialysis products market is dialysis chairs. According to a new draft report from Persistence Market Research, the market for hemodialysis chairs in India is growing quickly as the number of people with chronic kidney disease worldwide increases.

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee in a 14–1 vote recommended approval of a Pfizer drug that is a biosimilar compound to epoetin alfa (Amgen’s brand name anemia drug Epogen). The committee voted to support the biosimilar drug for approval of all four of Epogen’s clinical indications, making it the first biosimilar of an erythropoiesis-stimulating agent in the US recommended for approval by an FDA advisory committee.

Cara Therapeutics (Stamford, CT) released positive data about its uremic pruritus product, intravenous CR845, which targets peripheral kappa opioid receptors.

Keryx Pharmaceuticals (Boston) announced that the US Food and Drug Administration (FDA) will review its drug Auryxia (ferric citrate) for use in patients who have iron deficiency anemia and non-dialysis–dependent chronic kidney disease (CKD). Ferric citrate is a phosphate binder indicated for controlling serum phosphorus levels, typically in patients with CKD who are on dialysis.

A review for the new use of the drug should be complete by Nov. 6, 2017, according to

The search for effective treatments for non-dialysis–dependent chronic kidney disease (NDD-CKD) is gaining renewed interest. In the United States, more than one and a half million people suffering from stages 3 to 5 non-dialysis dependent NDD-CKD have iron deficiency anemia, but no oral iron supplements have yet been approved by the FDA for use for the condition. Likewise, no FDA-approved phosphate binders exist for use in NDD-CKD.

Fresenius Medical Care North America (FMCNA), a division of Fresenius Medical Care, has been busy forming partnerships with national insurers. FMCNA announced a partnership in March 2017 with Humana Inc. with plans for a new program to improve care and health outcomes for Humana’s members with end stage renal disease (ESRD). In February 2017, FMCNA announced a partnership with Cigna in a national program to lower the cost and improve quality of care for people with ESRD who are undergoing dialysis.

The US Food and Drug Administration (FDA) has approved a new filter from Nephros (River Edge, NJ).

In early March 2017, Nephros received 510(k) clearance to market its EndoPur™ Endotoxin 10-Inch Filter.

The filter is designed to provide hemodialysis-quality water to dialysis machines. It fits into existing filter cartridge housings of the reverse osmosis (RO) water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPur™ has an endotoxin barrier with the smallest pore size on the market, the company announced.

The National Institute for Health and Care Excellence (NICE), has approved everolimus (brand name Afinitor, manufactured by Novartis) for routine use as a regular National Health Service (NHS) treatment option for patients with advanced renal cell carcinoma (RCC). NICE provides evidence-based guidelines on health care for the NHS and other medical organizations in England.

Drug combinations against advanced kidney cancer are the new focus in research and treatment, say many oncology experts. One combination in the news is nivolumab and ipilimumab, each an immunotherapy drug. The first approved (2016) combination for advanced kidney cancer is everolimus plus lenvatinib.

Other combinations, which include some of the aforementioned drugs, are also being tested, in a new era that medical oncologist James Hsieh is calling the Golden Era for advances against kidney cancer.

More control over vascular access in dialysis can be an important part of dialysis self-care.

In addition to dialysis centers training patients to handle their own vascular access when motivated to learn, a new maker of venous access, Advent Access (Singapore), is positioning itself as a “disruptive” new technology that will further help patients on dialysis.

After a rejection last year by the U.S. Food and Drug Administration (FDA) and the need for a complete response letter explaining data, Amgen (Thousand Oaks, CA) now has gained FDA approval for its drug Parsabiv. Approved in early February, the drug treats secondary hyperparathyroidism (secondary HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Eisai (Tokyo), a maker of cancer and neurological therapies, is closer to gaining a proven new benefit for its renal cancer treatment, lenvatinib (Kisplyx), in Germany, where 15,000 people develop renal cell carcinoma (RCC) every year.

Recent news of a new kidney cancer treatment in early studies and insight into when to use alpha blockers to treat kidney stones top recent industry developments.

The US Food and Drug Administration (FDA) approved Rayaldee (calcifediol) (OPKO Health, Miami, FL) extended-release capsules for treatment of secondary hyperparathyroidism (SHPT). The approval applies only to treating adults with SHPT who have CKD stage 3 or 4 and serum total 25-hydroxyvitamin D <30 ng/mL.

Rayaldee has a patented design intended to increase serum total 25-hydroxyvitamin D (prohormone) levels to targeted levels and also to decrease elevated intact parathyroid hormone (iPTH). It is the first drug approved for this specific purpose.

The world’s largest provider of dialysis services now has a new business: a regenerative medicine company. Frensenius Medical Care (Bad Homburg, Germany) has opened the doors of Unicyte AG, a subsidiary that will undertake research into kidney and liver diseases, diabetes, and cancer.

Acombination therapy called Byvalson has been approved by the FDA to treat high blood pressure.

Taken together once a day in a fixed dose pill from Allergan (Parsippany, NJ; Dublin, Ireland), the two drugs—Nebivolol and Valsartan—work by using different mechanisms to lower blood pressure.

A research team at the University of Michigan (U-M), Ann Arbor, has devised a technique to use cultured kidney cells to simulate the way kidneys clear drug compounds.

One year after the biosimilar version of Zarxio, manufactured by Novartis and a competitor of Amgen’s drug Neupogen, landed on the market, the US Food and Drug Administration (FDA) has approved a second biosimilar drug. (Neupogen is used to treat neutropenia, lack of certain white blood cells caused by cancer, bone marrow transplant, or chemotherapy).

Fresenius Kidney Care is the new name of the dialysis division of Fresenius North America.

“We created this name to better communicate our approach to helping people with kidney disease thrive and continue doing the things that matter most to them,” said Ron Kuerbitz, CEO of Fresenius Medical Care North America. “The Fresenius Kidney Care name underscores the focus and attention that our caregivers provide to our patients’ unique health needs at more than 2200 dialysis centers across the nation.”

Baxter International Inc. announced in mid-March 2016 it had enrolled the first patient in a US clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter (Deerfield, IL), and DEKA Research & Development (Manchester, NH).

The trial is designed to study more frequent, extended-duration nighttime home HD therapy (high dose HD), which will be performed in dialysis facilities as well as in homes. The study will assess product safety and adequacy of dialysis.

Fresenius is now working to settle a lawsuit brought against it by plaintiffs regarding its dialysate products GranuFlo and NaturaLyte. Although the company notified its own dialysis centers about cardiac arrest events in some patients using the products, it allegedly did not inform other dialysis centers at the same time it sent an internal memo, the New York Times reported.

The two Fresenius dialysates neutralize the normal buildup of acid in the blood.

A newly approved merger seals one of the largest recent dialysis business deals. U.S. Renal Care (USRC, Plano, TX) announced in early January that it had finalized its deal to merge with DSI Renal. U.S. Renal Care, already the nation’s third largest provider of dialysis, will now operate 300 outpatient clinics, 147 home dialysis programs, and 26 acute care hospital contracts throughout the United States.

The anemia drug Feraheme (ferumoxytol (AMAG Pharmaceuticals, Waltham, MA) will now carry the FDA’s strongest warning. The FDA has stipulated that the drug must carry a boxed warning that states “serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol).”

The US Food and Drug Administration has approved Sanofi’s new diabetes drug formulation Toujeo (insulin glargine injection, 300 U/mL). The drug, which may be used by patients with either type 1 or type 2 diabetes, is a once-daily long-acting basal insulin.

Rockwell Medical has won drug approval by the US Food and Drug Administration (FDA) for a new anemia drug, Triferic (soluble ferric pyrophosphate or SFP).

The results from two phase 3 clinical studies demonstrated that Triferic was effective in maintaining “hemoglobin during the treatment period in iron-replete patients with hemodialysis-dependent chronic kidney disease in the studies as conducted,” according to FDA documents.

DaVita, the second largest provider of dialysis services in North America, is acquiring its first operations in Europe—in Germany.

What makes the deal particularly interesting is that Germany is the headquarters of the largest provider of dialysis services and products worldwide. Fresenius Medical Care is based in Bad Homburg, Germany. Fresenius North America is well established, but DaVita is just starting to get its feet wet across the oceans.

Around press time, news appeared that a drug once used to lower cholesterol was showing promise for patients with chronic kidney disease (CKD).

DaVita dialysis services is now reaping the benefits of its acquisition of a rival firm, DSI Renal.

In the third quarter of 2011, DaVita reported a higher profit because of new revenue streams from its acquisition. According to Associated Press (AP), for the quarter that ended September 30, DaVita earned $135.3 million, an improvement over the $119.4 million for the same time period last year. The company’s revenue increased 9.5 percent to $1.8 billion for the period.


Noteworthy mergers continue in the dialysis field. In late 2010, Liberty Dialysis of Mercer Island, Washington, merged with Renal Advantage in Brentwood, Tennessee, to create the number three firm in dialysis. Then in August, Fresenius Medical Care, a global provider of dialysis services and products, agreed to purchase the newly fashioned Liberty Dialysis Holdings for $1.7 billion.

Affymax, a company based in Palo Alto, CA, and its partner, Takeda Pharmaceuticals of Osaka, Japan, are making a bid for U.S. Food and Drug Administration (FDA) approval of the drug peginesatide, used to treat anemia in patients with advanced chronic kidney disease.

The companies have submitted a new drug application to the FDA. The drug is a synthetic PEGylated peptidic compound that binds to and activates the erythropoietin receptor. It acts like an erythropoiesis-stimulating agent.

Pfizer Inc. announced in June that it had asked European Union regulators to approve axitinib as a treatment for advanced kidney cancer.

According to Bloomberg Businessweek, Pfizer is seeking to market the drug to patients who have not had good results with other therapies for advanced kidney cancer. Many pharmaceutical business analysts are calling axitinib one of Pfizer’s top drug candidates.

For the fourth consecutive year since a federal data registry program was launched in 2007, Fresenius’ chronic kidney disease data registry has been the largest registry for nephrology. Fresenius and dozens of other registries have gained admittance as official registries in the federal program that requires physician quality-indicator reporting. That program, the Physicians Quality Reporting System (PQRS) is administered by the Centers for Medicare and Medicaid Services (CMS).

Pfizer Inc. says that its oral drug Inlyta (axitinib) has been granted European approval for use as a second-line therapy for kidney cancer patients, according to Reuters News. The drug, already approved in the United States, has been approved in Europe as a second-line treatment for patients who have not responded to initial chemotherapy.

DaVita recently settled a whistle-blower lawsuit from 2002 regarding its anemia management practices with a $55 million payment but no admission of wrongdoing by the company.

In March 2012, Affymax and Takeda Pharmaceuticals obtained U.S. Food and Drug Administration approval for Omontys (peginesatide) injection, a once-a-month treatment for anemia in patients with chronic kidney disease (CKD) who are on dialysis.

New approaches to long-term vascular access problems are arriving. One group is working in trials to get approval for its system for creating vascular access. The other team is working to prevent needle sticks that penetrate into and through the vascular graft walls, causing profuse bleeding.

Two international bodies approved the drug Soliris (eculizumab) for orphan drug status, giving manufacturer Alexion Pharmaceuticals, Inc., of Cheshire, Conn., special consideration on its way through the drug approval process. Orphan drugs are those that most likely wouldn’t be developed because of the rarity of the disease they treat, in this case atypical hemolytic uremic syndrome (aHUS).

Patients with kidney disease who are treated at for-profit dialysis centers are 20 percent less likely to be informed about the transplantation option than are those at nonprofit centers, according to a study at Johns Hopkins University School of Medicine. Controversy about this finding played out recently during a forum in Oregon, when angry state insurers and others confronted representatives from for-profit dialysis centers about the transplantation option.


In late spring, a federal judge in Tennessee awarded the United States government $82.6 million from three companies in a Medicare fraud case brought by whistleblowers.

The companies, Renal Care Group, Renal Care Group Supply Company, and Fresenius Medical Holdings, were found liable for recklessly disregarding federal law when they billed Medicare for home dialysis supplies and equipment.

DaVita’s acquisition in late May of HealthCare Partners, which has 700 staff physicians and a network of 8300 independent doctors, signaled a major dedication to a new strategy, a move that gives DaVita a major foundation with an accountable care organization (ACO), a critical component solidified by the federal Patient Protection and Affordable Care Act.

DiaSource opened virtual doors in May as a dialysis business that promises low-cost dialysis to employers who participate with DiaSource providers in its network.

The other side of the equation is that DiaSource must attract dialysis providers in an area and sign them on to participate as providers so they can serve these smaller businesses.

The employer clients are generally self-insured employers who cannot easily afford to offer dialysis treatments economically within a small employee base.

Rockwell Medical completed a second late-stage study in September (the earlier, identical late-stage trial ended in July) and announced that its experimental drug has met the main goal of improving hemoglobin levels in adult patients with chronic kidney disease, Reuters reported.

The renal denervation device market has several systems approved for use in Europe, but none so far has been approved by the U.S. Food and Drug Administration (FDA). Renal denervation is a catheter-based ablation procedure used to treat patients with high blood pressure resistant to drugs.

For years, medical researchers have sought an early test to determine how well a transplant patient’s body is accepting an organ. Half of kidney recipients have organ failure within 10 years of a transplant.

Now, two companies have produced a test that may help to solve the problem of detecting early rejection.

The Centers for Medicare and Medicaid Services decided against coding edits that would have changed the way vascular access procedures are billed.

Coding guardians at the American Society of Diagnostic and Interventional Nephrology (ASDIN) and other industry groups formed a coalition that succeeded in keeping certain codes and definitions unchanged.

In 2011, Fresenius successfully concluded a 5-year pilot project that showed costs could be lowered with an integrated provider program focusing on patients with chronic kidney disease (CKD). By capturing patients earlier in the course of CKD, the provider of dialysis services and products was able to show noteworthy savings in the project sponsored by the Centers for Medicare & Medicaid Services (CMS).

Several kidney cancer drugs made the news lately.

The U.S. Food and Drug Administration (FDA) recently approved Inlyta (axitinib) for treating advanced renal cell carcinoma (RCC) after treatment with a systemic therapy has failed. An oral drug made by Pfizer, Inlyta blocks certain receptors that can influence tumor growth and also the progression of kidney cancer. Forty percent to 65 percent of patients whose cancer progresses after first-line therapy go on to receive a second-line treatment, the company said.

Abbott Laboratories is expanding its pipeline into renal care drugs with a new addition, a potential kidney treatment from the privately held Danish company Action Pharma, Abbott announced May 3.

The company will pay $110 million to buy the compound, which is in midstage clinical testing, according to an Associated Press report. The drug is designed to prevent acute kidney injury in patients undergoing major cardiac surgery.

Abbott Laboratories (Chicago) currently has about 20 drugs in midstage or late-stage clinical trials, versus about eight in 2009, and these include potential treatments for change to chronic kidney disease (CKD) as well as for multiple sclerosis and liver cancer.

Abbott has more drugs in its pipeline because of acquisitions and licensing deals, according to a report on the Wall Street Journal MarketWatch site. CKD has become an area of focus.

Fresenius, DaVita, and American Renal Holdings (parent company of American Renal Associates)—all providers of outpatient dialysis services—announced better than expected financial results for the year ending December 31, 2011.

In Corona, Calif., Watson Pharmaceuticals announced it would continue to sell its iron deficiency treatment, Ferrlecit, in the United States until the end of the year. A Swiss arbiter ruled in favor of Watson. In March 2008, Ferrlecit’s maker, Sanofi-Aventis, let Watson know that their joint agreement for supply and distribution of Ferrlecit would expire on Feb. 18, 2009, according to a filing with the U.S. Securities and Exchange Commission. Sanofi-Aventis noted it would expect damages if any sales occur after that date.

Asahi (Japan-based Asahi Kasei Kuraray Medical) has agreed to partner with NxStage Medical to take advantage of their joint expertise and resources as makers of dialyzers. Asahi will deliver a better loan rate to NxStage, while NxStage will deliver manufacturing and business expertise to the Asian manufacturer of dialyzers. Dialyzers are part of dialysis machines that act as the filters, with patient’s blood in one compartment and dialysate in the neighboring compartment.

The United States could save more than $1 billion in five years if just 15 percent of all dialysis patients used peritoneal dialysis (PD), according to a study published in Clinical Therapeutics (2009; 31:880–888). PD is an alternative to hemodialysis that uses the peritoneal membrane around the stomach to filter the patient’s blood with the help of dialysate that is infused and drained by catheter.

French drugmaker Sanofi recently reported on two developments in diabetes drug development: results of a successful clinical trial of a Sanofi drug combined with another drug to lower hemoglobin A1c levels and a new partnership that intends to create a stem cell–based drug to treat diabetes.

DaVita announced in May 2013 that it had set aside $300 million in case the company would be required to pay a federal fine, revealed CEO Kent Thiry, during what he termed a “sober” conference call to announce quarterly results. Eventually, the company had set aside a total of $414 million, so it would be prepared to pay for a potential violation of the False Claims Act when the time came.

The settlement money has finally come due, and amounted to $387 million plus interest accrued between February and October of this year.

Medicare has miscalculated the costs of dialysis drugs in bundled costs, according to a report released by the US Health and Human Services Office of the Inspector General in late March.

Two companies involved in water filtration and purification inked a non-exclusive agreement in March to distribute dialysis filters to U.S. and Canadian dialysis clinics.

The companies, Nephros and Mar Cor Purification, will distribute Nephros’ ultrafilters.


A toxic leak into water sources in West Virginia and extreme winter weather over Canada and the United States had people working hard to keep dialysis facilities safe and operational in recent weeks.

Acceleron Pharma (Cambridge, MA), focuses on designing protein therapeutics for cancer and rare diseases. Two of its new products under development involve patients with renal conditions.

Acceleron and Celgene Corp., based in Summit, NJ, are jointly developing a drug candidate called sotatercept, a fusion protein that acts by increasing the production of mature red blood cells into circulation, which may benefit patients with advanced chronic kidney disease.


La Jolla Pharmaceutical Company announced on March 10 that its lead experimental drug, which treats chronic kidney disease, met its primary goal of improving kidney function as measured by blood filtering through the kidneys.


DaVita, the second largest provider of dialysis services in the United States, has agreed to a framework for “a global resolution with government officials for both the 2010 and the 2011 U.S. Attorney Physician Relationship Investigations,” the company shared in its most recent financial report.


The U.S. Food and Drug Administration (FDA) is revising, for the first time since 2009, its draft guidance on how to present and publish information about off-label use of a drug or device.

Fresenius’ North America unit this year will launch a drug approved in late November by the U.S. Food and Drug Administration.

Velphoro (sucroferric oxyhydroxide) received approval for controlling serum phosphorus levels in dialysis patients with chronic kidney disease.

One of the latest innovations in home dialysis is a machine that weighs less and uses less water.

Switzerland-based Debiotech SA and Singapore-based AWAK Technologies have joined forces to develop and manufacture a miniaturized home hemodialysis machine they call DialEase.

DialEase uses Debiotech’s mini peritoneal dialysis equipment and a novel sorbent technology for fluid purification developed by AWAK.

Biopharmaceutical company Rockwell Medical in Wixom, MI, reported its third quarter results for calendar year 2013. With a modest increase in sales of 3.2 percent over the same quarter in 2012, the company also had a gross profit of $1.6 million, the same amount as in the company’s 2012 third quarter.

U.S. Renal Care (USRC), based in Plano, TX, has nearly doubled its business reach by acquiring Ambulatory Services of America (ASA), an evidence-based practice of dialysis and radiation oncology services in Brentwood, TN.

The merger will nearly double USRC’s current patient volume to about 14,000 with operations in more than 200 outpatient, home, and specialty hospital dialysis programs and facilities, business website Modern Healthcare reported. ASA had 79 dialysis centers at the time of the merger.


A new type of erythropoietin product may be coming soon for patients with chronic and advanced kidney disease in whom anemia may develop.

NxStage, which is a maker of home-based dialyzers as well as models for health care setting use, set a revenue record in its last financial quarter and had noteworthy sales of its home-use dialysis systems.

Revenue for the second quarter of 2013 increased 11 percent to $65.5 million. The same quarter in 2012 showed revenue of $59 million.

Cytori Therapeutics, Inc., has received a patent for a new method of treating renal diseases using adipose-derived regenerative cells (ADRCs), cells derived from fat tissue. The company announced that the patent covers treatment of a broad range of renal disorders, including acute kidney disease as well as chronic kidney disease (CKD).

The patent also covers several ways of delivering the cells, including directly to the kidney or to the renal blood vessels.

The U.K.’s National Institute for Health and Clinical Excellence (NICE) has issued a final appraisal decision and rejected the drug axitinib (marketed by Pfizer as Inlyta) for the treatment of advanced kidney cancer. NICE also recently provided management guidance for patients with hyperphosphatemia, which often accompanies chronic kidney disease (CKD).

Aeo Pharmaceuticals of Cambridge, MA, said that its partner Astellas Pharma, whose world headquarters is in Japan, would not seek marketing approval for an experimental kidney cancer drug in Europe, Reuters reported.

This news comes just after a U.S. Food and Drug Administration (FDA) panel decision in early May, with a 13-to-1 vote in favor of not approving the drug immediately and of recommending an additional clinical trial before the drug tivozanib could be approved for renal cell cancer. A final decision will come after July 26.

Dialysis provider Fresenius Medical Care has announced its second accountable care organization (ACO) arrangement. The latest deal is with ApolloMed ACO of Glendale, CA, announced in May. Fresenius will provide integrated health care management for its patients with ESRD.

On April 30, the U.S. Food and Drug Administration (FDA) granted NxStage Medical clearance for its new high-flow capabilities with the NxStage System One, a portable hemodialysis system cleared for home use. With this clearance, NxStage Medical, based in Lawrence, Mass., expects to begin offering its System One with new higher flow capabilities in the United States later in 2013.

The higher flow capabilities will allow practitioners to adjust the duration and frequency of patient prescriptions for dialysis at home.

Medgenics has announced early data from its phase II clinical trial with the EPODURE biopump device. This trial used the company’s proprietary biopump to deliver the drug erythropoietin, or EPO, to anemic patients with chronic kidney disease who had not yet begun dialysis.

The company, based in Karmiel, Israel, has produced biopump applications for treating several chronic diseases, including hepatitis C, and is in the early stages of developing a biopump application that would treat hemophilia.

A phase three trial showed that an already approved drug, sorafenib (Nexavar, manufactured by Bayer Pharma), and tivozanib share a similar survival period for patients with advanced renal cell cancer.


NxStage, a manufacturer of home-based dialysis equipment like the NxStage System One (to date the only portable home system cleared by the U.S. Food and Drug Administration for use in home hemodialysis) and other dialysis products, announced fourth-quarter and year-end results for 2012.

Amgen finished 2012 with lower fourth-quarter profits—reporting a net income of $788 million—despite an 11 percent increase in revenue for the quarter to $4.42 billion. Increased spending on research and development and other administrative costs led to the 16 percent decline for the quarter compared to 2011.

Abbott Laboratories announced a 35 percent decrease in profits in the fourth quarter of 2012. Despite an increase in sales of more than 4 percent, net earnings for the quarter were $1.05 billion, down from $1.62 billion in 2011.

Keryx Biopharmaceuticals recently announced that the phase III clinical trial of its drug Zerenex (ferric citrate) successfully met its predetermined end points. Conducted under a Special Protocol Agreement, the study assessed the oral ferric iron–based compound for the treatment of hyperphosphatemia in patients with ESRD who are receiving dialysis.

Two Canadian biotechnology firms—the publicly traded Isotechnika Pharma and privately held Aurinia Pharmaceuticals—will combine forces to concentrate on the nephrology therapeutic market. The companies will join together under the Aurinia banner to focus on developing the calcineurin inhibitor voclosporin, an immunosuppressant, for approval.

A novel iron supplement therapy under development at Rockwell Medical significantly reduced erythropoietin-stimulating agent (ESA) dosing by 37 percent over the course of a recent 9-month study. A randomized placebo-controlled phase II clinical trial demonstrated that the drug—soluble ferric pyrophosphate (SFP)—met the primary end point of lowering ESA use in patients with end stage renal disease (ESRD) receiving hemodialysis.

Questions are being raised about the effectiveness of axitinib as a life-prolonging second-line treatment for patients with advanced renal cancer.

Baxter International, one of the largest health care suppliers in the world, is in discussions with Swedish dialysis product maker Gambro in a bid to buy the company for $4 billion. The acquisition would be a long-sought addition to Baxter’s dialysis holdings, according to the Wall Street Journal (WSJ).

Just after Baxter bid $4 billion to purchase Gambro, a maker of dialysis-related products, in the hope of being a dominant force in the dialysis marketplace, there is another news item out of Gambro’s Brentwood, Tennessee home base. Ambulatory Services of America (ASA), of Brentwood, has bought a majority interest in six dialysis centers and an acute dialysis program in the Los Angeles area.

A health care industry analyst has made a prediction for 2013 that American companies like Denver-based DaVita, the second largest provider of dialysis services in the United States, may be best positioned to “benefit from changes in the health care market stemming from Obamacare.”

Dialysis takes numerous hours of patients’ time per week, which can greatly interfere with family, work, and recreational schedules. Now Fresenius Medical Care North America (FMCNA), the largest provider of dialysis services in the United States, has established more than 140 nighttime dialysis center sites.

In July 2015, Fresenius issued a voluntary recall of more than 1.8 million 6.4-L bottles of NaturaLyte Liquid Bicarbonate Concentrate (see FDA website for details about the recalled units). The concentrate is formulated for use with a three-stream hemodialysis machine that is calibrated for acid and bicarbonate concentrates, the FDA noted.

During the first three quarters of 2008, Fresenius Medical Care, a renal services company, had a strong showing in its international markets and in the United States. Chief Executive Officer Ben Lipps gave an optimistic assessment for the company in the near future: “Despite cost pressures, an uncertain economic environment, and volatile currency developments, we are confident of achieving our midterm financial targets for 2010.”

Renal Advantage of Brentwood, Tenn., has several new dialysis centers in its national circle, thanks to the completion of an acquisition by its parent company. RA Group Holdings acquired National Renal Alliance, based in Franklin, Tenn.

The combined company, number three in the field after Fresenius and DaVita, will now operate 136 dialysis centers in 18 states, and serve about 11,000 patients.

Two Nephrology TreatmentTrends™ publications released late last year analyze the market trends of products that help nephrologists and renal dietitians manage their patients’ renal anemia, hyperphosphatemia, and secondary hyperparathyroidism. The reports, issued by BioTrends Research Group, are based on survey results from 204 nephrologists and 201 renal dietitians in the United States.

Patients with high blood pressure may have a new way to improve their health beyond bypassing the salt shaker and taking blood pressure medications. A national clinical trial is finding that the Minneapolis-based CVRx® Rheos ® System is effective in treating early-stage heart failure.

Amgen Inc. recently completed its acquisition of KAI Pharmaceuticals for $315 million. Initially agreed to on April 10, Amgen said the move was spurred by the “compelling” phase 2A trial results of KAI-4169, KAI’s compound to treat hyperthyroidism. The deal calls for Amgen to make a loan to KAI so it can plan late-stage trials of the drug.

Researchers at Translational Genomics Research Institute (TGen) of Phonenix, AZ, have developed a promising way to isolate exosomes—tiny cell components that contain genetic and other useful information—from urine.

Exosomes are being widely studied because they may contain biomarker clues that could serve as the basis of new early diagnostic tests for chronic kidney disease (CKD). Found in urine, these cellular components may provide information about the very earliest changes in kidney function.

The injectable iron drug Feraheme (ferumoxytol) received European approval to treat iron deficiency anemia in adult patients with chronic kidney disease on dialysis. This triggered a $15 million milestone payment from Takeda Pharmaceutical company to its partner AMAG Pharmaceuticals, the manufacturer of Feraheme.

Hydra Biosciences, Inc., a leader in the field of transient receptor potential channel modulation, and Boehringer Ingelheim announced that they have entered into a worldwide research collaboration and license agreement to identify small-molecule transient receptor potential inhibitors, to focus on renal disease treatments.

Hydra Biosciences, a biopharmaceutical company based in Cambridge, MA, develops drugs to treat several conditions involving ion channels.

Several kidney-related drug trials have recently yielded results. ProMetic Life Sciences (Laval, Quebec), announced that it had successfully completed its phase 1b clinical trial of PBI-4050 in patients with chronic kidney disease (CKD).

Welcome to the expanding market for factory-produced low-potassium lettuce aimed at people with chronic kidney disease (CKD).

NephroGenex, a drug development firm based in Raleigh, NC, plans to raise $34.5 million in a secondary public offering, according to the Triangle Business Journal. The goal is to increase the number of clinical trial sites to test the company’s drug Pyridorin, a treatment for diabetic nephropathy, commonly stemming from acute kidney injury (AKI) and diabetes.

Outset Medical (San Jose, CA) has eclipsed an initial funding level of $9.5 million thanks to Warburg Pincus, a private equity investment firm. Warburg Pincus reported recently that it had invested $60 million in the company.

For the first time, the U.S. Food and Drug Administration (FDA) has approved a fixed-dose antihypertensive pill combining angiotensin-converting enzyme inhibitor and beta blocker compounds. The drug, brand name Prestalia (Symplmed, Cincinnati, Ohio), contains perindopril arginine, an angiotensin-converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker.

The NephroCheck test system is now being marketed by Ortho Clinical Diagnostics to help identify risk of acute kidney injury (AKI). The urine test is designed to detect both insulin-like growth factor binding protein 7 and tissue inhibitor of metalloproteinases, factors associated with AKI.

DaVita started using the Nephros hemodiafiltration system in a pilot program based in its Colorado Springs facility to learn how the system compares with traditional hemodialysis in patient care. Nephros gained approval from the FDA in 2012 for the hemodiafiltration system, which may enhance traditional hemodialysis by filtering out a range of different-sized contaminants.

A Fresenius product used in dialysis was recalled after one death by bacterial infection and other cases of sickness after certain lots of the drug were administered.

The U.S. Food and Drug Administration (FDA) issued the class 1 recall related to the use of Fresenius NaturaLyte Liquid Bicarbonate Concentrate. The FDA reported that laboratory tests identified Halmonas species, a bacterial strain typically found in water with a high salt concentration, in the product during its shelf life.

DaVita, the second largest provider of dialysis services in the United States, is rearranging at the top. DaVita HealthCare Partners is making moves in both of its divisions: DaVita, which provides dialysis care, and HealthCare Partners (HCP), which manages and operates medical groups and affiliated physician networks in several states and provides integrated care management for about 829,000 managed care patients, according to the company website (

AMG 416, a drug designed to treat secondary hyperparathyroidism (SHPT), has met its endpoints in a phase 3 clinical trial, the manufacturer Amgen in Thousand Oaks, CA, reported in July.

SHPT is common and can be severe in patients with chronic kidney disease (CKD) and in those receiving dialysis. At first, the parathyroid glands produce more parathyroid hormone in an effort to maintain normal serum calcium and phosphorus levels. However, as CKD progresses, SHPT can develop as the body shifts to a combination of abnormal levels of parathyroid hormone (PTH), calcium, and phosphorus.

"The progressive nature of ADPKD means that kidney function gets worse over time, eventually leading to end-stage renal disease. This progression happens more rapidly for some patients than others.” said Michal Mrug, M.D., Associate Professor at the University of Alabama at Birmingham and investigator on the REPRISE trial. “Today’s approval is great news for adults at risk of rapidly progressing ADPKD because by slowing the decline in kidney function, this therapy may give them more time before kidney transplant or dialysis.”