Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial)
Not Applicable
Recruiting
- Conditions
- Chronic kidney disease
- Registration Number
- JPRN-UMIN000013375
- Lead Sponsor
- Fujita Health University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1.Hypersensitivity to the study drug formulation 2.Cerebrovascular disorders occurring within last 6 months 3.Pregnant women 4.Hemorrage (hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) 5.Complication of active peptic ulcer disease, 6.Complication of serious hepatic disease 7.Complication of malignancy 8.Patients judged to be inappropriate by the physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. delta-eGFR, 50% decrease in estimated glomerular filtration rate (eGFR) , induction of renal replacement therapy 2. Composite outcome:50% decrease in eGFR+induction of renal replacement therapy
- Secondary Outcome Measures
Name Time Method 1. Urinary protein, urinary albumin 2. Urinary markers of tubular injury:neutrophilgelatinase-associated lipocalin,Lipocalin-2 (NGAL), liver-type fatty acid-binding protein (L-FABP), midkine 3. pulse wave velocity (PWV) , cardio-ankle vascular index (CAVI) 4. high-sensitivity C-reactive protein (hs-CRP) 5. Blood Cholesterol (HDL, LDL, & Triglycerides) 6. Lectin-like oxidized LDL receptor 1 (LOX-1) index 7. addition of antihypertensive drugs 8. Cardiovascular events