Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/500825/2016
Effective from01/04/2017
KeywordsRenal insufficiency, chronic kidney disease (CKD)
DescriptionThe document provides guidance on the conduct of clinical studies with medicinal products intended to prevent or slow progression of chronic renal insufficiency. It defines treatment goals, study designs, outcome measures and data analyses.

Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

Effective from: 01/04/2017


Published: 20/10/2016


Published: 01/07/2014


Published: 20/09/2010

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