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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013375
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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/ctr_e/ctr_view.cgi?recptno=R000015600


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