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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    174
  • sponsor
    Joe Chan
Updated on 26 January 2021
kidney transplant

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.

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.

Details
Condition Organ Transplantation, Renal transplant, Organ Transplant - Pediatric, Organ Transplant, Kidney Transplantation, kidney transplant, renal transplantation, kidney transplants
Treatment Placebo oral capsule, Omacor
Clinical Study IdentifierNCT03018041
SponsorJoe Chan
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
-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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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