National Kidney Foundation funds research initiative that will improve health outcomes of patients with chronic kidney disease, decrease the number of people who develop kidney failure and the need for dialysis and transplant
January 9, 2019, New York, NY – 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 LancetDiabetes 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.”
“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 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.
NKF Professional Membership
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.
Kidney Disease Facts
In the United States 30 million adults are estimated to have chronic kidney disease—and most aren’t aware of it. 1 in 3 American adults are at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).
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.