Open label, randomized controlled trial of Pemafibrate to evaluate renopotective effect in CKD patients

JRCT ID: jRCT1071240094

Registered date:09/01/2025

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: outpatients with hypertriglyceridemia and chronic kidney disease
• Date of first enrollment: 23/11/2020
• Target sample size: 140
• Study type: Interventional
• Intervention(s): pemafibrate is added to conventional treatment for 1 year.

Outcome(s)

• Primary Outcome: Change of urinary protein amount at 12 months

Secondary Outcome

Efficacy evaluation; change from baseline in follow items at 12 months after study start
(Lipid metabolism; Triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very low-density lipoprotein, intermediate-density lipoprotein, small-dense low-density lipoprotein cholesterol, oxidant low-density lipoprotein cholesterol, apolipoproteinA1, apolipoproteinA2, apolipoproteinB, apolipoproteinB48, fibroblast growth factor 19, hepatic triglyceride lipase
Renal function; creatinine, estimated glomerular filtration rate, blood urea nitrogen, cystatin C
Urinary marker; albuminuria, liver-type fatty acid-binding protein, neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, alpha1-microglobulin, beta2-microglobulin
Inflammation; high sensitive C-reactive protein, Interleukin-1beta, Interleukin-6, S100A8/A9
Liver function; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase
Mineral and bone metabolism; calcium, phosphate, intact parathyroid hormone, alkaline phosphatase, bone-specific alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteoprotegerin, osteopontin, fetuinA, fibroblast growth factor 23, bone morphogenetic protein-2, bone morphogenetic protein-4, bone morphogenetic protein-7, bone morphogenetic protein-9)
Safety evaluation; Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Serum TG 150 mg/dL and over and under 1000 mg/dL at agreement.
2.UPCR 0.15 g/gCr and over for 3months at least.
3.Age 20 years and over
4.Outpatient of Kyushu university nephrologist for more than three months.
5.With written agreement

Exclude criteria

1.Using pemafibrate or some fibrates within 1 month before agreement.
2.Pregnant woman or woman being pregnancy during trial and lactating woman.
3.Allergy reaction to pemafibrate
4.Severe hepatic dysfunction or hepatic cirrhosis;Child-Pugh B or C or biliary obstruction.
5.Cholecystolithiasis
6.Serum Cr 2.5 mg/dL and over or CCr under 40 mL/min
revised in November 2022 as follows; Patients on dialysis therapy or expected to require renal replacement therapy during the study period
7.Severe nephrosis necessary much amount of immunosuppressive agents or steroid.
8.After kidney transplantation
9.Cardiovascular events within 3 months before agreement.
10.Using cyclosporin or rifampicin
11.Familial hypercholesterinemia or familial hypoalphalipoproteinemia
12.History of myositis or myopathy or elevation of serum CPK; over 5 times ULN
13.Active malignancy
14.Severe infection

Related Information

• Primary Sponsor: Nakano Toshiaki
• Secondary ID(s): UMIN000042284