Hypertriglyceridemia with Chronic Kidney Disease
Conditions
Interventions
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-base
Sponsors
Tamura Kouichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 or over 2) CKD Patients, eGFR >/= 20, = 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR slope [12 weeks to 104 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, dyslipidemia, renal, hepatic, and other biomarker parameters Renal, cardiovascular and skeletal muscle events Vital signs Exploratory item | — |
Contacts
Public ContactSho Kinguchi
Yokohama City University Medical Center
Outcome results
None listed