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Clinical and Experimental Nephrology
Published in: Clinical and Experimental Nephrology 6/2018

Open Access 01-12-2018 | Guideline

Guidelines for clinical evaluation of chronic kidney disease

AMED research on regulatory science of pharmaceuticals and medical devices

Authors: Eiichiro Kanda, Naoki Kashihara, Kunihiro Matsushita, Tomoko Usui, Hirokazu Okada, Kunitoshi Iseki, Kenichi Mikami, Tetsuhiro Tanaka, Takashi Wada, Hirotaka Watada, Kohjiro Ueki, Masaomi Nangaku, Research Working Group for Establishing Guidelines for Clinical Evaluation of Chronic Kidney Disease

Published in: Clinical and Experimental Nephrology | Issue 6/2018

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Excerpt

In the clinical phase of drug development, it is important to establish appropriate endpoints. In general, to verify hard endpoints such as death, many subjects need to be studied over a long period of time, resulting in a large-scale clinical trial. To promote the early development of drugs, it is essential to establish methods for evaluating the clinical usefulness of treatment drugs by predicting long-term prognosis utilizing methods such as appropriate surrogate endpoints. In the field of nephrology, treatment of chronic diseases such as chronic kidney disease (CKD) and diabetic kidney disease (DKD) is not satisfactory, and demands for the development of new drugs are strong. In Europe and the US, the use of surrogate endpoints for such diseases is being debated. …
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Metadata
Title
Guidelines for clinical evaluation of chronic kidney disease
AMED research on regulatory science of pharmaceuticals and medical devices
Authors
Eiichiro Kanda
Naoki Kashihara
Kunihiro Matsushita
Tomoko Usui
Hirokazu Okada
Kunitoshi Iseki
Kenichi Mikami
Tetsuhiro Tanaka
Takashi Wada
Hirotaka Watada
Kohjiro Ueki
Masaomi Nangaku
Research Working Group for Establishing Guidelines for Clinical Evaluation of Chronic Kidney Disease
Publication date
01-12-2018
Publisher
Springer Singapore
Published in
Clinical and Experimental Nephrology / Issue 6/2018
Print ISSN: 1342-1751
Electronic ISSN: 1437-7799
DOI
https://doi.org/10.1007/s10157-018-1615-x

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