Unique ID issued by UMIN | UMIN000013375 |
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Receipt number | R000015600 |
Scientific Title | Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial) |
Date of disclosure of the study information | 2014/03/08 |
Last modified on | 2019/09/10 16:27:25 |
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
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
Japan |
Chronic kidney disease
Nephrology |
Others
NO
To investigate the clinical efficacy of purified EPA in patients with chronic kidney disease (CKD) In the long-term follow up, we investigate whether purified EPA decelerates the progress of CKD.
Efficacy
Exploratory
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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)
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
300
1st name | |
Middle name | |
Last name | Yukio Yuzawa |
Fujita Health University School of Medicine
Department of Nephrology
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan
0562-93-9245
hhayashi@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Hayashi |
Fujita Health University School of Medicine
Department of Nephrology
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan
0562-93-9245
hhayashi@fujita-hu.ac.jp
Fujita Health University School of Medicine
None
Self funding
Chita City Hospital, Okazaki City Hospital, TOYOTA Memorial Hospital, Tono Kosei Hospital, Saishukan Hospital
MOCHIDA PHARMACEUTICAL CO., LTD.
NO
藤田保健衛生大学病院(愛知県)、知多市民病院(愛知県)、岡崎市民病院(愛知県)、トヨタ記念病院(愛知県)、東濃厚生病院(岐阜県)、済衆館病院(愛知県)
2014 | Year | 03 | Month | 08 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 02 | Month | 14 | Day |
2013 | Year | 09 | Month | 10 | Day |
2014 | Year | 03 | Month | 08 | Day |
2019 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015600
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