Landmark Analysis Supports New Endpoints for Kidney Disease Trials

New York, NY – August 28, 2019 - The American Journal of Kidney Diseases (AJKD) will publish today an article summarizing the deliberations and recommendations from a Scientific Workshop that was a joint effort of the National Kidney Foundation (NKF),   the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

 

The report, titled “Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease” is the culmination of an ambitious multi-year project to evaluate whether change in slope of eGFR decline and albuminuria are valid endpoints to evaluate efficacy of new treatments for kidney disease. The project included extensive meta-analyses examining the largest compilation of data ever collected on CKD with nearly two million participants.  The findings may lead to expedited clinical trials and approved therapies to slow the progression of kidney disease.

 

“The results and conclusions presented in today’s report are a major advance in the kidney community’s decades-long search for practical and reliable endpoints for clinical trials in early-stage kidney disease,” said Kerry Willis PhD, NKF Chief Scientific Officer. “The NKF is grateful to the dedicated research team whose efforts made this possible, and to the FDA and EMA for their collaboration.”

 

The workshop pulled together hundreds of stakeholders, investigators, representatives from the FDA and EMA and the National Institutes of Health, Centers for Medicare and Medicaid Services, laboratory experts, pharmaceutical industry researchers, patients and others to review the data and give their analysis.

 

“We are pleased this report presenting the data findings and the workshop recommendations, along with five original investigation articles reporting on the metanalyses completed for the initiative have all now been published in high visibility journals, including Journal of the American Society of Nephrology (JASN), Lancet Diabetes and Endocrinology, and AJKD” said Director of the Analytical Team for the project Josef Coresh, MD, PhD, Johns Hopkins Bloomberg School of Public Health, Baltimore. “This combined data analyses from observation cohorts, clinical trials and simulation provides valuable insight into the design of study protocols for research in kidney disease.”

 

In the Editorial accompanying the workshop report the FDA writes, “From our vantage point, the landscape for drug development for chronic kidney diseases has changed dramatically over the last 10 years. We have arrived at this place because of efforts such as this and the willingness of the community to share data to answer important questions. We thank those who led and contributed to the workshop, and, in particular, those who shared their data, thus allowing us to move forward.”

 

“For our patients, early detection and early intervention to prevent progression are an essential part of improving outcomes and reducing the  number of patients who develop kidney failure and require kidney replacement therapy”, said Planning Committee Chair Andrew S. Levey, MD, Chief Emeritus of the Division of Nephrology at Tufts Medical Center, Boston, “We would be delighted if the results from this initiative move us even one step closer to identifying safe and efficacious therapies to impact the quality and duration of life for people with kidney disease.”

 

The article is published online and open to anyone for 90 days. It will then only be available to those subscribers to AJKD. Access the article by going to https://www.ajkd.org/article/S0272-6386(19)30883-2/fulltext.

 

Authors of the article are: Andrew S. Levey, MD, Ron T. Gansevoort, MD, PhD, Josef Coresh, MD, PhD, Lesley A. Inker, MD, MS, Hiddo L. Heerspink, PharmD, PhD, Morgan E. Grams, MD, MHS, PhD, Tom Greene, PhD, Hocine Tighiouart, MS, Kunihiro Matsushita, MD, PhD, Shoshana H. Ballew, PhD, Yingying Sang, MS, Edward Vonesh, PhD, Jian Ying, PhD, Tom Manley, RN, Dick de Zeeuw, MD, PhD, Kai-Uwe Eckardt, MD, Adeera Levin, MD, Vlado Perkovic, MBBS, PhD, Luxia Zhang, MD, PhD, and Kerry Willis, PhD.

The workshop report and supporting published metanalyses can be accessed from the NKF Website: www.kidney.org/CKDEndpoints

 

The American Journal of Kidney Diseases (AJKD), the official journal of the National Kidney Foundation, is recognized worldwide as a leading source of information devoted to clinical nephrology practice and clinical research. Articles selected for publication in AJKD must adhere to rigorous standards, supporting the journal's goal to communicate important new information in clinical nephrology in a way that strengthens knowledge and helps physicians to provide their patients with the highest standard of care.

 

Healthcare professionals can join NKF to receive access to tools and resources for both patients and professionals, discounts on professional education, and access to a network of thousands of individuals who treat patients with kidney disease.

 

In the United States, 37 million adults are estimated to have chronic kidney disease (CKD) – and most aren’t aware of it.  1 in 3 American adults is at risk for CKD.  Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity, a family history of kidney failure, and being age 60 or older. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are about 3 times more likely than Whites to develop end-stage kidney disease (ESKD or kidney failure). Compared to non-Hispanics, Hispanics are almost 1.3 times more likely to receive a diagnosis of kidney failure.