| Original language | English |
|---|---|
| Pages (from-to) | 1446-1475 |
| Number of pages | 30 |
| Journal | Clinical and experimental nephrology |
| Volume | 22 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2018 Dec 1 |
| Externally published | Yes |
Keywords
- Chronic kidney disease
- Dialysis
- End-stage renal disease
- Glomerular filtration rate
- Guideline
- Proteinuria
- Surrogate endpoint
ASJC Scopus subject areas
- Physiology
- Nephrology
- Physiology (medical)
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Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices. / Research Working Group for Establishing Guidelines for Clinical Evaluation of Chronic Kidney Disease.
In: Clinical and experimental nephrology, Vol. 22, No. 6, 01.12.2018, p. 1446-1475.Research output: Contribution to journal › Article › peer-review
}
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 -