The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Kidney Transplantation
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 filtr...
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.
Tracking Information
- NCT #
- NCT03018041
- Collaborators
- University of Oslo
- Rikshospitalet University Hospital
- Ullevaal University Hospital
- Drammen sykehus
- Elverum Hospital
- South-Eastern Norway Regional Health Authority
- Aalborg University Hospital
- Pronova BioPharma
- Haukeland University Hospital
- University Hospital of North Norway
- Investigators
- Study Director: My Svensson, MD, PhD University Hospital, Akershus Study Chair: Ivar Anders Eide, MD, PhD University Hospital, Akershus Study Chair: Branimir Draganov, MD Ullevaal University Hospital Principal Investigator: Joe Chan, MD University Hospital, Akershus Principal Investigator: Morten Reier-Nilsen, MD Drammen sykehus Principal Investigator: Tone Granseth, MD Elverum Hospital Principal Investigator: Nanna von der Lippe, MD, PhD Ullevaal University Hospital Principal Investigator: Bård Endre Waldum-Grevbo, MD, PhD Ullevaal University Hospital Principal Investigator: Per Olav Rui, MD Haukeland University Hospital
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