The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Omacor; Drug: Placebo Oral Capsule

• Registration Number: NCT03018041
• Lead Sponsor: Joe Chan

Brief Summary

This is a long-term intervention study on the effects of marine n-3 PUFAs in renal transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation will have less decline in kidney transplant function compared to patients treated with placebo.

Detailed Description

The study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. Patients will be randomized to oral supplementation of marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.

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.

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Study Start: 2017-09-01
• Primary Completion: 2024-03-22
• Study Completion: 2025-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Renal transplant recipients over 18 years of age.
• 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 of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marine n-3 PUFAs	Omacor	3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).
Placebo	Placebo Oral Capsule	Corresponding placebo oral capsules with olive oil, three capsules daily.

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	156 weeks	Estimated by CKD-EPI equation

Secondary Outcome Measures

Name	Time	Method
Proteinuria	156 weeks	ACR and FE-protein
Body mass index	156 weeks
Plasma fatty acid levels	156 weeks	measured by gas chromatography
Blood pressure	156 weeks
Resting heart rate	156 weeks
Lipid and lipoprotein concentrations	156 weeks
Heart rate variability	156 weeks	Sub-study, participants from Akershus University Hospital only
Fatty acid levels in renal cortical tissue	156 weeks	Sub-study, participants from Akershus University Hospital only
Plasma inflammatory biomarkers	156 weeks
Fasting serum glucose / HbA1c	156 weeks
The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue	156 weeks	Sub-study, participants from Akershus University Hospital only
Markers of fibrosis in renal cortical tissue	156 weeks	Sub-study, participants from Akershus University Hospital only

Trial Locations

Locations (6)

Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway

Drammen Hospital; 🇳🇴 Drammen, Buskerud, Norway

Elverum Hospital; 🇳🇴 Elverum, Hedmark, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Ullevaal University Hospital; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway