The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
NCT ID: NCT03018041
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2017-09-01
2025-03-22
Brief Summary
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Detailed Description
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The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. Secondary endpoints include the following variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate, fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths.
Patients from Akershus University Hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (CADI) and markers of fibrosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Marine n-3 PUFAs
3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).
Omacor
As described in "Arms".
Placebo
Corresponding placebo oral capsules with olive oil, three capsules daily.
Placebo Oral Capsule
As described in "Arms".
Interventions
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Omacor
As described in "Arms".
Placebo Oral Capsule
As described in "Arms".
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable renal graft function, defined as eGFR \>30 ml/min at the last 2 visits.
* 6-60 months post-transplantation at randomization.
* Signed informed consent.
Exclusion Criteria
* Women who are pregnant or breastfeeding.
* Patients who participate in a clinical trial with other investigational drugs.
* Patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug Omacor or drugs or dietary supplements similar to the study drug.
* Any reason why, in the opinion of the Principal Investigator, the patient should not participate - E.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.
18 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Rikshospitalet University Hospital
OTHER
Ullevaal University Hospital
OTHER
Drammen sykehus
OTHER
Elverum Hospital
UNKNOWN
South-Eastern Norway Regional Health Authority
OTHER
Aalborg University Hospital
OTHER
Pronova BioPharma
INDUSTRY
Haukeland University Hospital
OTHER
University Hospital of North Norway
OTHER
Joe Chan
OTHER
Responsible Party
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Joe Chan
MD, PhD
Principal Investigators
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My Svensson, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Akershus
Ivar Anders Eide, MD, PhD
Role: STUDY_CHAIR
University Hospital, Akershus
Branimir Draganov, MD
Role: STUDY_CHAIR
Ullevaal University Hospital
Joe Chan, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Akershus
Morten Reier-Nilsen, MD
Role: PRINCIPAL_INVESTIGATOR
Drammen sykehus
Tone Granseth, MD
Role: PRINCIPAL_INVESTIGATOR
Elverum Hospital
Nanna von der Lippe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Bård Endre Waldum-Grevbo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Per Olav Rui, MD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Toralf Melsom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Renathe Rismo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Locations
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Akershus University Hospital
Lørenskog, Akershus, Norway
Drammen Hospital
Drammen, Buskerud, Norway
Elverum Hospital
Elverum, Hedmark, Norway
Ullevaal University Hospital
Oslo, Oslo County, Norway
Haukeland University Hospital
Bergen, , Norway
University Hospital of North Norway
Tromsø, , Norway
Countries
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Other Identifiers
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2016-003537-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2016/1652 (REK)
Identifier Type: -
Identifier Source: org_study_id
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