RATIONALE AND PROTOCOL OF THE JAPAN KIDNEY ASSOCIATION–PEMAFIBRATE INTERVENTION FOR CHRONIC KIDNEY DISEASE PATIENTS STUDY (JKAPI-CKD STUDY)

 

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https://storage.unitedwebnetwork.com/files/1099/ed75d8551d401cfb76db7c96277a0577.pdf
RATIONALE AND PROTOCOL OF THE JAPAN KIDNEY ASSOCIATION–PEMAFIBRATE INTERVENTION FOR CHRONIC KIDNEY DISEASE PATIENTS STUDY (JKAPI-CKD STUDY)

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Sho
Kinguchi
Sho Kinguchi kinguchi@yokohama-cu.ac.jp Yokohama City University Center Hospital Department of Nephrology and Hypertension Yokohama Japan *
Kouichi Tamura tamukou@yokohama-cu.ac.jp Yokohama City University Center Hospital Department of Nephrology and Hypertension Yokohama Japan -
Yuichiro Yano y.yano@juntendo.ac.jp Juntendo University Faculty of Medicine Department of General Medicine Tokyo Japan -
Naoki Kashihara kashinao@med.kawasaki-m.ac.jp Kawasaki Medical School Department of Nephrology Okayama Japan -
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In recent years, elevated triglyceride (TG) levels have attracted increasing attention as a residual cardiovascular risk factor in patients with chronic kidney disease (CKD). Pemafibrate, a selective peroxisome proliferator-activated receptor αmodulator and a novel therapeutic option for hypertriglyceridemia in patients with CKD, has been reported to cause fewer kidney-related adverse events than conventional fibrates. Although appropriate management of hypertriglyceridemia may contribute to improved renal outcomes, evidence for the renoprotective effects of pemafibrate has not yet been established. The aim of this study is to investigate the effect of pemafibrate on the eGFR slope in patients with CKD.

The JKAPI-CKD study is a multicenter, open-label, randomized controlled trial. Eligible participants are adults (≥18 years) with CKD and hypertriglyceridemia who have not received pemafibrate or any fibrate therapy within 12 weeks prior to enrollment. Key inclusion criteria are: (i) eGFR 20≤, <60 mL/min/1.73 m², and (ii) fasting TG ≥150 mg/dL or non-fasting TG ≥175 mg/dL. Participants will be randomized in a 1:1 ratio to either the pemafibrate treatment group (standard therapy plus pemafibrate 0.1–0.4 mg/day) or the control treatment group (standard therapy according to guidelines, excluding fibrates). The target sample size is 2,200 participants, and the observation period is 112 weeks. The primary endpoint is the chronic eGFR slope, defined as the eGFR slope from week 12 to week 104.

Participant enrollment and follow-up are ongoing.

The JKAPI-CKD study will provide new insights into the potential renoprotective effects of pemafibrate in CKD patients with hypertriglyceridemia. The findings are expected to establish novel evidence for the treatment of hypertriglyceridemia with pemafibrate in patients with CKD. (Clinical trial registration: jRCTs031240097)

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