The COVID-19 pandemic has brought new urgency to the need for alternatives to in center dialysis for people with kidney failure. Historically, integrating patient preferences into device development has been limited. Developments in the kidney community in recent years, including the KidneyX and the Advancing American Kidney Health initiative, have accelerated development of transformative devices for kidney replacement therapy.
Session on Collaborating for Innovation to Support KidneyX
Eric Hargan, Deputy Secretary at the US Department of Health and Human Services (HHS) began the second day by sharing HHS’s priorities for kidney care. First, to increase efforts at preventing, detecting, and slowing the progression of kidney diseases. Second, to provide more treatment options to people with kidney failure. Third, to increase the number of transplantable organs and develop wearable and artificial kidneys.
The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.
The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.
The American Society Nephrology (ASN) is pleased to announce that Raymond C. Harris, MD, FASN, has been selected as the incoming ASN Co-Chair for the Kidney Health Initiative (KHI). Dr. Harris will serve a three-year term, starting in January 2019. Dr. Harris will succeed Prabir Roy-Chaudhury, MD, PhD, FASN, who has served six years as KHI’s founding co-chair.
While dialysis is a life-saving therapy for patients with end stage kidney disease (ESKD), a variety of symptoms occur following treatment that significantly diminishes the quality of life of people living with kidney disease. A 2009 study published in the Clinical Journal of the American Society of Nephrology (CJASN) reported that patients on maintenance dialysis experience 11 unique symptoms. Patients have identified the need to alleviate these symptoms as a key research area, prioritizing it above other health outcomes. Alleviation of these symptoms could result in increased quality of life and better patient-reported outcome measures. Despite the patient demand for new therapies to address these symptoms, no drug or device has been approved by the US Food and Drug Administration (FDA) to date.
The Advancing American Kidney Health initiative made developing an artificial kidney a national priority. The increased interest, investment, and innovation brought about by this policy highlight the need for new and improved infrastructure to facilitate innovation.
In early December 2018, Prabir Roy-Chaudhury, MD, PhD, FASN, the outgoing American Society of Nephrology Co-Chair for KHI, and Raymond C. Harris, MD, FASN, who began his term as Co-Chair for KHI in 2019, recorded a discussion with ASN Executive Vice-President Tod Ibrahim. This wide-ranging Kidney News podcast included Dr. Roy-Chaudhury’s evaluation of his six-year tenure and an outline of Dr. Harris’ vision for the future.
While there are many incentives to invest in rare diseases, well designed clinical trials are critical to getting the new therapies conceived by pharmaceutical companies to the people who need them.
Primary hyperoxaluria (PH) is a rare genetic kidney disease impacting fewer than 1000 people in the US. While many people with kidney disease are asymptomatic until they progress to kidney failure and can rely on dialysis or a transplant to replace their kidney function, the unique characteristics of PH cause severe symptoms early in life and make common kidney replacement therapies ineffective.
The Kidney Health Initiative (KHI) recently released a new website to inform the community about its mission, objectives, and membership. The new site also showcases the publications from completed projects since the formation of KHI in 2012.
For the first time, KHI’s research and recommendations are centralized and accessible to kidney health professionals, researchers, patients, and innovators. The redesigned website highlights: