Guidelines for clinical evaluation of chronic kidney disease

Eiichiro Kanda,Masaomi Nangaku,Hirokazu Okada,Kunitoshi Iseki,Kohjiro Ueki,Kenichi Mikami,Naoki Kashihara,Kunihiro Matsushita,Takashi Wada,Hirotaka Watada,Tetsuhiro Tanaka,Tomoko Usui

doi:10.1007/s10157-018-1615-x

Abstract

Guidelines for clinical evaluation of chronic kidney disease

Highlights

In the clinical phase of drug development, it is important to establish appropriate endpoints
Americans for replacing a hard endpoint of end-stage renal disease (ESRD) to indicate the effectiveness of treatments for chronic kidney disease (CKD)
3 years may be adopted as surrogate endpoints

Summary

Introduction

In the clinical phase of drug development, it is important to establish appropriate endpoints. 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 2018, Japanese Society of Nephrology established the Research Working Group for Establishing Guidelines for Clinical Evaluation of CKD, which published “Guidelines for Clinical Evaluation of Chronic Kidney Disease” in the Japanese Journal of Nephrology, 2018, vol 60, issue 2, 67–100. This is the English version of that report. The underlying reasons include absence of appropriate model animals due to the complicated pathophysiology of kidney disease and the difficulty of clinical trials [4]

Objectives

Methods

Results

Discussion

Conclusion