Design of the Japan Kidney Association-Pemafibrate Intervention for Chronic Kidney Disease patients Study (JKAPI-CKD study)

Abstract Background Hypertriglyceridemia has attracted considerable attention as a residual cardiovascular risk factor in patients with chronic kidney disease (CKD). Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, is a novel therapeutic option for hypertriglyceridemia in patients with CKD, and is associated with fewer kidney adverse events in this population compared with conventional fibrates. Although appropriate management of hypertriglyceridemia may contribute to improved kidney outcomes, evidence regarding the efficacy and safety of pemafibrate to reduce CKD progression is unknown. The aim of this study is to investigate the effect of pemafibrate on the rate of change in estimated glomerular filtration rate (eGFR) slope in patients with CKD. Methods The Japan Kidney Association-Pemafibrate Intervention for Chronic Kidney Disease patients (JKAPI-CKD) study is a prospective, multicenter, open-label, parallel-group, randomized controlled trial. The study will enroll 2200 adults with CKD, defined as eGFR ≥ 20 mL/min/1.73 m2 and 60 mL/min/1.73 m2, and hypertriglyceridemia (triglyceride level ≥ 150 mg/dL (fasting) or ≥ 175 mg/dL (non-fasting)) who have not received pemafibrate or conventional fibrates within 12 weeks prior to consent. Participants will be randomized in a 1:1 ratio to the pemafibrate group (guideline-based conventional therapy plus pemafibrate 0.1–0.4 mg/day) or the control group (guideline-based conventional therapy excluding fibrates). The observation period will be 104 weeks. The primary endpoint is the chronic eGFR slope, defined as the eGFR slope from weeks 12–104 after study initiation. Results On December 1, 2025, a total of 2328 participants had been enrolled, completing the participant enrollment. Conclusions The JKAPI-CKD study is anticipated to yield novel insights into the renoprotective effects of pemafibrate in patients with CKD and establish new evidence supporting its use for the management of dyslipidemia in this population.