An article published August 28 in American Journal of Kidney Diseases summarizes deliberations and recommendations from a scientific workshop that was a joint effort of the National Kidney Foundation, the Food and Drug Administration and the European Medicines Agency. Dr. Josef Coresh, professor in the Johns Hopkins Bloomberg School of Public Health’s department of epidemiology, served as director of the project’s analytical team.
The report, “Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease,” evaluates whether changing two key kidney function measurements — kidney filtration (also called estimated glomerular filtration rate, GFR) decline and albuminuria levels — are valid endpoints to evaluate efficacy of new treatments for kidney disease. Two analysis teams assembled data from over 100 clinical trials and observational studies. Detailed analyses show that under many circumstances these surrogate outcomes can provide a strong basis to decide if a treatment is effective using a shorter time and smaller study population than traditional clinical outcomes like counting the number of patients needing dialysis. The findings may lead to expedited clinical trials and approved therapies to slow the progression of kidney disease.
The project included extensive meta-analyses examining the largest compilation of data ever collected, including nearly two million participants, to understand the validity of surrogate outcomes in kidney disease.Friday Letter Submission, Publish on September 06