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

Joe Chan174 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

174

Conditions

Kidney Transplantation

Interventions

OmacorDRUG

As described in "Arms".

Placebo Oral CapsuleDRUG

As described in "Arms".

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Akershus University Hospital

Lørenskog, Akershus, Norway

Drammen Hospital

Drammen, Buskerud, Norway

Elverum Hospital

Elverum, Hedmark, Norway

Ullevaal University Hospital

Oslo, Oslo County, Norway

Outcomes

Primary Outcomes

Glomerular filtration rate

Estimated by CKD-EPI equation

Time frame: 156 weeks

Secondary Outcomes

Proteinuria

ACR and FE-protein

Time frame: 156 weeks

Plasma fatty acid levels

measured by gas chromatography

Time frame: 156 weeks

Plasma inflammatory biomarkers

Time frame: 156 weeks

Blood pressure

Time frame: 156 weeks

Resting heart rate

Time frame: 156 weeks

Fasting serum glucose / HbA1c

Time frame: 156 weeks

Lipid and lipoprotein concentrations

Time frame: 156 weeks

Body mass index

Time frame: 156 weeks

Heart rate variability

Sub-study, participants from Akershus University Hospital only

Time frame: 156 weeks

The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue

Sub-study, participants from Akershus University Hospital only

Time frame: 156 weeks

Data from ClinicalTrials.gov

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