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

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.

Keywords: Renal insufficiency, chronic kidney disease (CKD)

Current effective version

Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

Adopted Reference Number: EMA/CHMP/500825/2016 Legal effective date: 01/04/2017

Document history

Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

Adopted Reference Number: EMA/CHMP/500825/2016 Legal effective date: 01/04/2017

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)

Draft guideline on the clinical investigation of medicinal products to prevent development / slow progression of chronic renal insufficiency

Draft: consultation closed Consultation dates: 01/07/2014 to 01/01/2015 Reference Number: EMA/CHMP/355988/2014 Summary:

The aim of this guideline is to provide guidance on the clinical development of compounds used to prevent the development and to slow the progression of chronic renal insufficiency.

Concept paper on the need for the guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency

Draft: consultation closed Consultation dates: 22/07/2010 to 01/01/2011 Reference Number: EMA/CHMP/EWP/6054/2010