Guidelines for clinical evaluation of chronic kidney disease: AMED research on regulatory science of pharmaceuticals and medical devices

TY - JOUR

T1 - Guidelines for clinical evaluation of chronic kidney disease

T2 - AMED research on regulatory science of pharmaceuticals and medical devices

AU - Research Working Group for Establishing Guidelines for Clinical Evaluation of Chronic Kidney Disease

AU - Kanda, Eiichiro

AU - Kashihara, Naoki

AU - Matsushita, Kunihiro

AU - Usui, Tomoko

AU - Okada, Hirokazu

AU - Iseki, Kunitoshi

AU - Mikami, Kenichi

AU - Tanaka, Tetsuhiro

AU - Wada, Takashi

AU - Watada, Hirotaka

AU - Ueki, Kohjiro

AU - Nangaku, Masaomi

N1 - Funding Information: Acknowledgements This study was supported by the Research on Regulatory Science of Pharmaceuticals and Medical Devices of AMED. We would like to thank the following for their valuable advice and support in the preparation of this guideline: Toru Kawanishi, Director of National Institute of Health Sciences, Hajime Yasuhara, Managing Director of Showa University Medical Foundation, Takashi Kadowaki, Chairman of the Japan Diabetes Society, Kazuishi Sekino, Kinue Nish-ioka, Mutsuhiro Ikuma, Hiroyuki Murakami, Kayo Shinohara, Nori-kazu Hinamoto, Mototsugu Tanaka, Junichi Asano, Tomoko Iwata, Hiroaki Yamada, Ryuta Nakamura, Motoko Honda, Yoshiko Komura, and Takaaki Suzuki of Office of New Drug I/Office of new Drug II, Pharmaceuticals and Medical Devices Agency, Chiho Iseki of Okinawa Heart and Renal Association, Takao Inoue, Reiko Nakajima of Project of Translational and Clinical Research Core Centers AMED, and Masanobu Yamada and Eri Sugiyama of Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Welfare and Labour. Funding Information: Based on this situation, the “Research Working Group for Establishing Guidelines for Clinical Evaluation of CKD” was set up as a research funded by the Research on Regulatory Science of Pharmaceuticals and Medical Devices of the Japan Agency for Medical Research and Development (AMED). In this program, the Japanese Society of Nephrology and Japanese Society of Diabetes worked together to establish guidelines for the clinical evaluation of treatment drugs for CKD, in collaboration with the Pharmaceuticals and Medical Devices Agency, analyzed data of Japanese cohorts. The aim of the project is to enable appropriate and prompt approval review of newly developed drugs without discrepancy from international criteria based on evidence for Japanese CKD patients.

PY - 2018/12/1

Y1 - 2018/12/1

KW - Chronic kidney disease

KW - Dialysis

KW - End-stage renal disease

KW - Glomerular filtration rate

KW - Guideline

KW - Proteinuria

KW - Surrogate endpoint

UR - http://www.scopus.com/inward/record.url?scp=85049837314&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85049837314&partnerID=8YFLogxK

U2 - 10.1007/s10157-018-1615-x

DO - 10.1007/s10157-018-1615-x

M3 - Article

C2 - 30006871

AN - SCOPUS:85049837314

SN - 1342-1751

VL - 22

SP - 1446

EP - 1475

JO - Clinical and Experimental Nephrology

JF - Clinical and Experimental Nephrology

IS - 6

ER -