Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial)

Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial) - The renoprotective effects of purified EPA in a population with chronic kidney disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013375

Enrollment

300

Registered

2014-03-08

Start date

2013-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

Patients are given purified EPA (EPADEL Capsule) at a dose of 900 mg, teice a day after meals (total 1800 mg/day). Patients are not given purified EPA (EPADEL Capsule)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.CKD patients satisfying the criteria of stage G3~G4 (15=<GFR<60 ml/min/1.73m2) 2.Dyslipidemic patients who have already received HMG-CoA reductase inhibitor 3.Patients who have not received EPA treatment within last 3 months

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroki Hayashi

Fujita Health University School of Medicine Department of Nephrology

hhayashi@fujita-hu.ac.jp0562-93-9245

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026