UMIN-CTR Clinical Trial

Basic information
Public title	Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial)
Acronym	The renoprotective effects of purified EPA in a population with chronic kidney disease
Scientific Title	Outcomes in chronic Kidney disease by purified Eicosapentaenoic acids for the prevention of HAZardous events:A Multicenter rAndomized control trial (OKEHAZAMA Trial)
Scientific Title:Acronym	The renoprotective effects of purified EPA in a population with chronic kidney disease
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients are given purified EPA (EPADEL Capsule) at a dose of 900 mg, teice a day after meals (total 1800 mg/day).
Interventions/Control_2	Patients are not given purified EPA (EPADEL Capsule)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukio Yuzawa
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Zip code
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan
TEL	0562-93-9245
Email	hhayashi@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroki Hayashi
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Zip code
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan
TEL	0562-93-9245
Homepage URL
Email	hhayashi@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chita City Hospital, Okazaki City Hospital, TOYOTA Memorial Hospital, Tono Kosei Hospital, Saishukan Hospital
Name of secondary funder(s)	MOCHIDA PHARMACEUTICAL CO., LTD.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date	2013 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 08 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015600