Change in Estimated GFR and Albuminuria as End Points in Clinical Trials: A Viewpoint From the FDA

It is a promising time for drug development for chronic kidney diseases. Recent randomized controlled trials in patients with diabetic kidney disease have reported success in slowing disease progression, and drug development for rare and uncommon kidney diseases is increasing. The larger nephrology community has also come together under various initiatives to address barriers to drug development and ensure incorporation of the patient voice. However, challenges remain, particularly for drug development for common chronic kidney diseases.