Japan Kidney Association-Pemafibrate Intervention for Chronic Kidney Disease patients Study: JKAPI-CKD study

JRCT ID: jRCTs031240097

Registered date:20/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertriglyceridemia with Chronic Kidney Disease
• Date of first enrollment: 16/08/2024
• Target sample size: 2200
• Study type: Interventional

Intervention(s)

Pemafibrate Treatment group: Pemafibrate (0.1 to 0.2 mg orally twice a day, morning and evening) is administered orally for 104 weeks, in addition to treatment according to guidelines of Evidence-based Clinical Practice Guideline for CKD 2023, or Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases, other than therapy with fibrates.
The dosage may be adjusted according to the hepatic or renal conditions, and the maximum dose is 0.2 mg twice daily.
Treatment should be administered according to the most recent package insert.
Control group: Participants are treated according to guidelines of Evidence-based Clinical Practice Guideline for CKD 2023, or Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases, other than therapy with fibrates.

Outcome(s)

• Primary Outcome: eGFR slope [12 weeks to 104 weeks]

Secondary Outcome

Safety, dyslipidemia, renal, hepatic, and other biomarker parameters
Renal, cardiovascular and skeletal muscle events
Vital signs
Exploratory item

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Aged 18 or over
2) CKD Patients, eGFR >/= 20, < 60 mL/min/1.73m2 : within 16 weeks prior to ICF
3) TG >= 150 mg/dL (fasting) or 175 mg/dL (casual) : within 16 weeks prior to ICF
4) Not changed medications for dyslipidemia, antihypertensive, or diabetes within 12 weeks prior to ICF.
5) Patients with written consent from themselves.

Exclude criteria

1) Patients who received pemafibrate or fibrates within 12 weeks prior to ICF.
2) Patients with contraindications in the latest package insert of pemafibrate.
3)Patients with proteinuria > 5 g/gCr spot urine UPCR or albuminuria > 3000 mg/gCr UACR.
4) TG >= 500 mg/dL (fasting or casual)
5) Poor control hypertension: systolic blood pressure >= 180 mmHg, diastolic blood pressure >=110 mmHg
6) Poor control diabetes: HbA1c >= 8.5%
7) CK level > 5 times UNL
8) eGFR < 20mL/min/1.73m2 within 16 weeks prior to ICF, renal dialysis or kidney transplant
9) Malignant tumors under treatment (excluding intraepithelial tumors)
10) Another interventional trial or study participants at the same time
11) Patients who are ineligible by the site principal investigator or sub-investigator

Related Information

• Primary Sponsor: Tamura Kouichi
• Source(s) of Monetary Support: Kowa Company, Ltd.