Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators
The 2018 workshop sponsored by the National Kidney Foundation (NKF) in collaboration with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) explored the predictive performance of change in albuminuria and estimated glomerular filtration rate (eGFR) slope to evaluate whether both biomarkers qualify as surrogate end points in drug development studies in early stages of chronic kidney disease (CKD). The data presented constitute the largest meta-analyses of data derived from observational studies and randomized controlled trials in CKD currently available, and we congratulate the investigators for this accomplishment.