The largest compilation of data collected on chronic kidney disease was recently examined by the National Kidney Foundation, the FDA and the European Medicines Agency, according to a press release from the National Kidney Foundation.
The groups concluded a scientific workshop to review the results of a major, multi-year meta-analysis that examined data on nearly two million participants. These clinical trials may lead to treatments that drastically improve the lives of people with kidney disease.
Attendees of the joint scientific workshop, Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease, were presented the results of the analysis and recommendations on whether alternate biomarkers – albuminuria, changes in the rate/sloop of glomerular filtration rate (GFR) decline, and GFR and albuminuria in combination – can be used to predict the effect of a treatment on the progression to kidney failure in clinical trials in early stages of chronic kidney disease.
“This extensive meta-analysis of endpoints for chronic kidney disease builds upon previous research which recommended a 30[%] or 40% decline in GFR as the endpoint for clinical trials in some CKD populations. However, we’ve found that these recommended endpoints are less applicable to the clinical development of drugs targeted at earlier stages of kidney disease and for many drugs with possible hemodynamic effects,” Kerry Willis, PhD, chief scientific officer of the National Kidney Foundation, said in the release. “How to overcome these obstacles was the driving force behind today’s scientific workshop and this multi-year research project.”
The meta-analysis was presented in two parts at the workshop. One part included data from more than 49 randomized clinical trials representing 44,816 patients. The second part included data from a consortium of international observational cohorts. Urine protein was evaluated in in 19 cohorts with 600,000 participants, and 22 cohorts with 1.3 million participants were used to analyze GFR slopes. The research was conducted at Tufts Medical Center, Johns Hopkins University, University of Utah and Groningen University in the Netherlands.
“For more than 2 years, some of the world’s leading researchers have compiled and analyzed extensive data which will be useful in both clinical practice and future clinical trials for kidney disease,” Andrew S. Levey, MD, workshop chair and professor of medicine at Tufts University School of Medicine, said in a press release. “The work presented over the past 2 days will help move us closer to developing medications to arrest kidney disease in its earliest stages before patients progress to end-stage renal disease and are faced with life-threatening complications and only dialysis or a transplant as options to survive.” - by Jake Scott
Disclosure: The study was supported by grants to the National Kidney Foundation to support the initiative on Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease from the following: Alexion, Astellas, AstraZeneca, Aurinia, Bayer, Boehringer-Ingelheim, Calliditas, Gilead, Ironwood, Janssen, Kyowa Hakko Kirin, Merck, Novartis, Novo-Nordisk, Reata, Retrophin and Tricida.