First Reports from Ambitious Kidney Disease Clinical Trial Endpoints Workshop to be Published in The Lancet Diabetes and Endocrinology
NEW YORK, /PRNewswire/ -- The first two original investigation analytical reports to come from an extraordinary National Kidney Foundation joint workshop with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease (CKD) will be published in the prestigious medical journal The Lancet Diabetes and Endocrinology.
The two reports to be published online today and in The Lancet Diabetes and Endocrinology's print edition in February will shed more light on how to design clinical trials for regulatory approval of therapeutics to slow the progression of kidney dysfunction in the earlier stages of CKD.
"These first two reports are exciting and support the premise that in certain populations change in albuminuria can be used to assess treatment effects and predict the risk of kidney disease progression in early stages of CKD," said Kerry Willis, PhD, Chief Science Officer of NKF. "It is our hope that this research can lead to new treatments that will improve outcomes for all those living with kidney disease."
One report is titled "Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies" and is authored by a team led by Josef Coresh, MD, PhD, Professor of Epidemiology at Johns Hopkins and Chair, CKD-Prognosis Consortium, along with Lesley A. Inker, MD, Associate Professor Nephrology, Tufts University and Principal Investigator, Chronic Kidney Disease Epidemiology Collaboration. This data collection and metanalyses was funded by NKF and the National Institute of Diabetes and Digestive and Kidney Disease.
"Kidney disease is harmful and common. It progresses slowly in many patients which allows opportunities for intervention," Dr. Inker said. "However, current trials cannot be designed to intervene early in the disease course. Albuminuria (or proteinuria) is an early marker of kidney damage and is common in many kidney diseases, in particular diabetes and glomerular disease. These papers showed how changes in albuminuria can be used to determine whether treatments are effective at slowing down CKD progression."
"Changes in albuminuria over a fairly short time provide information about longer-term risk of end-stage kidney disease," the authors report in the article. "Combined with data from clinical trials, simulations, and biological plausibility, the data provides a foundation for how to use average change in albuminuria as a surrogate endpoint for chronic kidney disease progression."
The other study report is titled "Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomized clinical trials" and is authored by a team led by Hiddo J. L. Lambers-Heerspink, PhD, Professor of Pharmacology, University of Groningen, and Dr. Inker. "This study supports using change in albuminuria as a surrogate endpoint for progression of CKD in clinical trials, particularly in patients with high albuminuria," the authors report in The Lancet. "Further research will be needed to determine how to best design therapeutic trials in CKD using change in albuminuria as an endpoint to assure that it accurately estimates the clinical benefit."
The reports emerged from the March 2018 workshop held jointly by NKF, the FDA and the EMA, where multi-disciplinary experts gathered to review years of meta-analysis for nearly two million participants, the largest compilation of data ever collected on chronic kidney disease. The group reviewed research that supports using early markers of kidney disease progression as endpoints in clinical trials.
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The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.
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SOURCE National Kidney Foundation