EMiRA: The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Marine n-3 PUFAs 3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA). |
Drug: Omacor
As described in "Arms".
Other Names:
|
| Placebo Comparator: Placebo Corresponding placebo oral capsules with olive oil, three capsules daily. |
Drug: Placebo Oral Capsule
As described in "Arms".
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Glomerular filtration rate [156 weeks]
Estimated by CKD-EPI equation
Secondary Outcome Measures
- Proteinuria [156 weeks]
ACR and FE-protein
- Plasma fatty acid levels [156 weeks]
measured by gas chromatography
- Plasma inflammatory biomarkers [156 weeks]
- Blood pressure [156 weeks]
- Resting heart rate [156 weeks]
- Fasting serum glucose / HbA1c [156 weeks]
- Lipid and lipoprotein concentrations [156 weeks]
- Body mass index [156 weeks]
- Heart rate variability [156 weeks]
Sub-study, participants from Akershus University Hospital only
- The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue [156 weeks]
Sub-study, participants from Akershus University Hospital only
- Markers of fibrosis in renal cortical tissue [156 weeks]
Sub-study, participants from Akershus University Hospital only
- Fatty acid levels in renal cortical tissue [156 weeks]
Sub-study, participants from Akershus University Hospital only
Other Outcome Measures
- Adverse events [156 weeks]
Incl. number of graft rejections and losses, cardiovascular events and deaths
- Adverse reactions [156 weeks]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Akershus University Hospital | Lørenskog | Akershus | Norway | 1478 |
| 2 | Drammen Hospital | Drammen | Buskerud | Norway | 3004 |
| 3 | Elverum Hospital | Elverum | Hedmark | Norway | 2409 |
| 4 | Haukeland University Hospital | Bergen | Norway | 5021 | |
| 5 | Ullevaal University Hospital | Oslo | Norway | 0450 | |
| 6 | University Hospital of North Norway | Tromsø | Norway |
Sponsors and Collaborators
- Joe Chan
- 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
- Principal Investigator: Toralf Melsom, MD, PhD, University Hospital of North Norway
- Principal Investigator: Renathe Rismo, MD, PhD, University Hospital of North Norway
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016/1652 (REK)
- 2016-003537-18