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

Current effective version

PDF iconAdopted 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

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

Effective from: 01/04/2017

Published: 20/10/2016

Published: 01/07/2014

Published: 20/09/2010

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