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

Joe Chan

Status and phase

Completed

Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: Placebo Oral Capsule

Drug: Omacor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03018041

2016-003537-18 (EudraCT Number)

2016/1652 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.