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

Kidney Transplantation Clinical Trial

— EMiRA  

Official title:

The Long-term Effect of Marine n-3 Polyunsaturated Fatty Acid Supplementation on Glomerular Filtration Rate and Development of Fibrosis in the Renal Allograft: a Randomized Double Blind Placebo Controlled Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03018041
• Other study ID #: 2016/1652 (REK)
• Secondary ID: 2016-003537-18
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Omacor
As described in "Arms".
• Placebo Oral Capsule
As described in "Arms".

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Drammen Hospital	Drammen	Buskerud
Norway	Elverum Hospital	Elverum	Hedmark
Norway	Akershus University Hospital	Lørenskog	Akershus
Norway	Ullevaal University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø

Sponsors (11)

Lead Sponsor	Collaborator
Joe Chan	Aalborg University Hospital, Drammen sykehus, Elverum Hospital, Haukeland University Hospital, Pronova BioPharma, Rikshospitalet University Hospital, South-Eastern Norway Regional Health Authority, Ullevaal University Hospital, University Hospital of North Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Incl. number of graft rejections and losses, cardiovascular events and deaths	156 weeks
Other	Adverse reactions		156 weeks
Primary	Glomerular filtration rate	Estimated by CKD-EPI equation	156 weeks
Secondary	Proteinuria	ACR and FE-protein	156 weeks
Secondary	Plasma fatty acid levels	measured by gas chromatography	156 weeks
Secondary	Plasma inflammatory biomarkers		156 weeks
Secondary	Blood pressure		156 weeks
Secondary	Resting heart rate		156 weeks
Secondary	Fasting serum glucose / HbA1c		156 weeks
Secondary	Lipid and lipoprotein concentrations		156 weeks
Secondary	Body mass index		156 weeks
Secondary	Heart rate variability	Sub-study, participants from Akershus University Hospital only	156 weeks
Secondary	The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue	Sub-study, participants from Akershus University Hospital only	156 weeks
Secondary	Markers of fibrosis in renal cortical tissue	Sub-study, participants from Akershus University Hospital only	156 weeks
Secondary	Fatty acid levels in renal cortical tissue	Sub-study, participants from Akershus University Hospital only	156 weeks