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

Authors :
Sugawara, Yuka
Kanda, Eiichiro
Hamano, Takayuki
Itano, Seiji
Okada, Hirokazu
Tomori, Koji
Watanabe, Yusuke
Asakura, Wataru
Isaka, Yoshitaka
Iseki, Kunitoshi
Usui, Tomoko
Suzuki, Yusuke
Tanaka, Mototsugu
Nishimura, Rimei
Fukami, Kei
Matsushita, Kunihiro
Wada, Jun
Watada, Hirotaka
Ueki, Kohjiro
Kashihara, Naoki
Source :
Clinical & Experimental Nephrology. Sep2024, Vol. 28 Issue 9, p847-865. 19p.
Publication Year :
2024

Abstract

Background: For the development of pharmaceutical products in kidney field, appropriate surrogate endpoints which can predict long-term prognosis are needed as an alternative to hard endpoints, such as end-stage kidney disease. Though international workshop has proposed estimated glomerular filtration rate (GFR) slope reduction of 0.5–1.0 mL/min/1.73 m /year and 30% decrease in albuminuria/proteinuria as surrogate endpoints in early and advanced chronic kidney disease (CKD), it was not clear whether these are applicable to Japanese patients. Methods: We analyzed J-CKD-DB and CKD-JAC, Japanese databases/cohorts of CKD patients, and J-DREAMS, a Japanese database of patients with diabetes mellitus to investigate the applicability of eGFR slope and albuminuria/proteinuria to the Japanese population. Systematic review on those endpoints was also conducted including the results of clinical trials published after the above proposal. Results: Our analysis showed an association between eGFR slope and the risk of end-stage kidney disease. A 30% decrease in albuminuria/proteinuria over 2 years corresponded to a 20% decrease in the risk of end-stage kidney disease patients with baseline UACR ≥ 30 mg/gCre or UPCR ≥ 0.15 g/gCre in the analysis of CKD-JAC, though this analysis was not performed on the other database/cohort. Those results suggested similar trends to those of the systematic review. Conclusion: The results suggested that eGFR slope and decreased albuminuria/proteinuria may be used as a surrogate endpoint in clinical trials for early CKD (including diabetic kidney disease) in Japanese population, though its validity and cutoff values must be carefully considered based on the latest evidence and other factors. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
13421751
Volume :
28
Issue :
9
Database :
Academic Search Index
Journal :
Clinical & Experimental Nephrology
Publication Type :
Academic Journal
Accession number :
179166812
Full Text :
https://doi.org/10.1007/s10157-024-02514-6