Guidelines for clinical evaluation of chronic kidney disease in early stages

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2024年7月6日

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Yuka Sugawara,
Eiichiro Kanda,
Takayuki Hamano,
Seiji Itano,
Hirokazu Okada,
Koji Tomori,
Yusuke Watanabe,
Wataru Asakura,
Yoshitaka Isaka,
Kunitoshi Iseki,
Tomoko Usui,
Yusuke Suzuki,
Mototsugu Tanaka,
Rimei Nishimura,
Kei Fukami,
Kunihiro Matsushita,
Jun Wada,
Hirotaka Watada,
Kohjiro Ueki,
Naoki Kashihara,
Masaomi Nangaku

摘要

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.