The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation (NCT03018041) | Clinical Trial Compass
CompletedPhase 3
The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
Norway174 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.