Recent clinical trials in fluid therapies, COVID-19 treatment, and sepsis management were presented at Kidney Week 2021 to keep nephrologists up to date in critical care medicine: The Balanced Solutions in Intensive Care Study (BaSICS) trial (1, 2) of balanced solution versus 0.9% saline in critically ill patients; the Efficacy and Safety of Baricitinib for the Treatment of Hospitalized Adults with COVID-19 (COV-BARRIER) trial (3); and the Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS) trial (4) of vitamin C, thiamine, and hydrocortisone on ventilator- and vasopressor-free days in sepsis.
A reduced dose of the inexpensive oral methylprednisolone reduced the risk of kidney failure by 41% over 4 years in patients with immunoglobulin A (IgA) nephropathy in the Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study presented during Kidney Week 2021. The drug, however, was associated with an increased risk of severe infection, particularly in the first months of treatment. The TESTING trial results were among several results that promise to help solve “clinical conundrums” in the field of nephrology, presented during the High-Impact Clinical Trials session at Kidney Week 2021.
Patients with chronic kidney disease have a high symptom burden that can impact their outlook on life and self-confidence to manage disease. With the recognition of these features, nephrology teams can offer targeted solutions to help patients improve their quality of life, according to a presentation at Kidney Week 2021.
More than 60% of patients receiving dialysis reported feeling depressed, worried, or frustrated in a recent survey (1), said Daniel Cukor, PhD, director of behavioral health at the Rogosin Institute in New York. “There's a really high emotional toll being a patient with end stage renal disease [ESRD],”
Kidney patients have long complained that the diet recommended for them is bland, tasteless, and hard to follow. But that old advice is being challenged by new research that may offer more palatable alternatives to old dietary approaches to managing kidney disease.
During the Diet and CKD [Chronic Kidney Disease]: What to Eat, When to Eat, How to Eat session at Kidney Week 2021, a panel of speakers highlighted evidence backing the health benefits of plant-based diets, time-restricted eating, and culturally sensitive dietary interventions for Black, Latinx, or Hispanic patients with kidney disease.
Results from two major trials of sodium glucose co-transporter 2 (SGLT2) inhibitors, a class of drugs initially developed as a treatment for type 2 diabetes mellitus, add to evidence that the drugs may offer kidney-protecting benefits. The results were presented during the High-Impact Clinical Trials session at Kidney Week 2021.
The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial found that the SGLT2 inhibitor dapagliflozin provided heart and kidney benefits regardless of the cause of underlying kidney disease. Results from the Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Reduced Ejection Fraction (EMPEROR-Reduced) trial
Earlier this year, the American Society of Nephrology (ASN) launched “We’re United 4 Kidney Health,” an initiative that repositions nephrology as a specialty that embraces kidney health through early intervention, transplantation, innovation and patient choice, and equity. We’re United 4 Kidney Health presents a rallying cry that shows how the kidney community can advance the field by embracing four priorities:
INTERVENE EARLIER to prevent, diagnose, coordinate care, and educate.
TRANSFORM TRANSPLANT and increase access to donor kidneys.
ACCELERATE INNOVATION and expand patient choice.
ACHIEVE EQUITY and eliminate disparities.
ASN is committed to a world without kidney diseases, and the society
FibroGen's roxadustat was dreaming of being the first-in-class hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) for treatment of chronic kidney disease (CKD)-related anemia. FibroGen submitted its new drug application to the US Food and Drug Administration (FDA) in December 2019 and suggested roxadustat safety was comparable to placebo and comparable or superior to erythropoiesis-stimulating agents (ESAs) in its global trials.
The dream became a nightmare at the July 15, 2021, FDA Advisory Committee meeting, where a panel of 14 experts overwhelmingly advised against approval of roxadustat for use in anemic non-dialysis or dialysis patients. The FDA is not required to follow the
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.”
In a year in which hospitals have been battered by the COVID-19 pandemic, Outset Medical was ready with a product not only needed in healthcare settings, but also in homes. The company raised $125 million earlier in 2020 to make its product commercially viable, FierceBiotech
Dascena (Oakland, CA) received FDA breakthrough device designation for its Previse machine-learning algorithm to predict acute kidney injury (AKI). The Breakthrough Devices Program provides a prioritized review of a device submission to the FDA and lets manufacturers interact with agency experts to address topics as they arise during the premarket review phase.
The algorithm uses values of various heart rates, respiratory rate, temperature, serum creatinine, Glasgow Coma Scale score, and patient age to predict likelihood of AKI. The company demonstrated that its algorithm predicted AKI more than one day before patients would meet the clinical criteria for diagnosis, which is
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 drug is the first investigational non-steroidal, selective mineralocorticoid