chronic renal failure, dyslipidemia
Conditions
Interventions
add on pemafibrate for 12 months
same treatment as before trial
Sponsors
kyushu university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of urinary protein amount at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public Contactmai seki
Graduate School of Medical Sciences, Kyushu University Department of Medicine and clinical science
Outcome results
None listed