Two original investigation analytical reports to come from a National Kidney Foundation joint workshop with the FDA and the European Medicines Agency 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 chronic kidney disease.
The reports are being published in the medical journal, The Lancet Diabetes and Endocrinology.
“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.”
The first report, a meta-analysis looking at change in albuminuria and subsequent risk of ESKD, was authored by a team led by Josef Coresh, MD, PhD, professor of epidemiology at Johns Hopkins and chair of the CKD-Prognosis Consortium, along with Lesley A. Inker, MD, associate professor of nephrology at Tufts University and principal investigator of the Chronic Kidney Disease Epidemiology Collaboration. “Kidney disease is harmful and common. It progresses slowly in many patients which allows opportunities for intervention.” 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 wrote 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 second study report, “Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomized clinical trials” authored by a team led by Hiddo J. L. Lambers-Heerspink, PhD, professor of pharmacology, University of Groningen, and Inker, supports the idea of using albuminuria as a surrogate endpoint for CKD progression, particularly among patients with high albuminuria.
“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 researchers wrote.
The workshop, held jointly by NKF, the FDA and the EMA, had multidisciplinary experts review years of meta-analysis for nearly two million participants, the largest compilation of data collected on CKD, according to an NKF press release. The group reviewed research that supports using early markers of kidney disease progression as endpoints in clinical trials.
Disclosure: The data collection and metanalyses were funded by NKF and the National Institute of Diabetes and Digestive and Kidney Disease.