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Designing Trials for Treatments of Early Stages of Common Chronic Kidney Diseases

A scientific workshop of 90 stakeholders in nephrology, clinical trials, and other fields convened virtually in Dec. 2020 to discuss the validation of surrogate end points for chronic kidney disease (CKD) progression and their use in evaluating therapies in early CKD. The perceptions of patients, providers, and payors were heard during the workshop.

“There was consensus among the attendees that there is value to preventing the development and treating the progression of early CKD in people who are at high risk for progression, and that surrogate endpoints should be used to establish efficacy,” the authors report on behalf of the NKF/FDA advisory group. “Attendees also concluded that cost analyses should be holistic and include aspects beyond direct savings for treatment of kidney failure; and that safety data should be collected outside/beyond the duration of a clinical trial. Successful drug development and implementation of effective therapies will require collaboration across sponsors, patients, patient advocacy organizations, medical community, regulators, and payors.”

Source: American Journal of Kidney Diseases