Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency
Table of contents
| Keywords | Renal insufficiency, chronic kidney disease (CKD) |
| Description | The 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. |
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Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency (PDF/160.14 KB)
Adopted
First published: 20/10/2016
Last updated: 20/10/2016
Legal effective date: 01/04/2017
EMA/CHMP/500825/2016 -
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Overview of comments received on 'Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency’ (EMA/CHMP/355988/2014) (PDF/433.36 KB)
First published: 20/10/2016
Last updated: 20/10/2016 -
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Draft guideline on the clinical investigation of medicinal products to prevent development / slow progression of chronic renal insufficiency (PDF/159.45 KB)
Draft: consultation closed
First published: 01/07/2014
Last updated: 01/07/2014
Consultation dates: 01/07/2014 to 01/01/2015
EMA/CHMP/355988/2014 -
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Concept paper on the need for the guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency (PDF/79.01 KB)
Draft: consultation closed
First published: 20/09/2010
Last updated: 20/09/2010
Consultation dates: 22/07/2010 to 01/01/2011
EMA/CHMP/EWP/6054/2010