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The Effects of Omega-3 Fatty Acids in Renal Transplantation

NCT ID: NCT01744067

Last Updated: 2015-12-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

Detailed Description

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There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.

8 weeks after transplantation, if renal function has stabilized, patients with a eGFR\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.

Conditions

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Disorder Related to Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 fatty acids

2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks.

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acids

Intervention Type DRUG

2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)

Placebo

Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules 3 times a day (oral administration)

Interventions

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Omega-3 fatty acids

2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)

Intervention Type DRUG

Placebo

Placebo capsules 3 times a day (oral administration)

Intervention Type DRUG

Other Intervention Names

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Omacor Olive oil

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR\>30 ml/min. Signed informed consent.

Exclusion Criteria

* Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor \>75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Pronova BioPharma

INDUSTRY

Sponsor Role collaborator

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ivar Eide

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivar A Eide, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital Rikshospitalet

Oslo, * Other, Norway

Site Status

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.

Reference Type DERIVED
PMID: 34939013 (View on PubMed)

Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.

Reference Type DERIVED
PMID: 30125457 (View on PubMed)

Other Identifiers

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2012-004992-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012/1419

Identifier Type: OTHER

Identifier Source: secondary_id

2012/1419

Identifier Type: -

Identifier Source: org_study_id