The Effects of Omega-3 Fatty Acids in Renal Transplantation (ORENTRA)
|Disorder Related to Renal Transplantation||Drug: Omega-3 fatty acids Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.|
- Glomerular filtration rate [ Time Frame: 44 weeks ]Iohexol clearance
- Proteinuria [ Time Frame: 44 weeks ]Both ACR and FEPR
- Inflammation in the renal transplant [ Time Frame: 44 weeks ]Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.
- Fibrosis in the renal transplant [ Time Frame: 44 weeks ]As for inflammation
- Blood pressure [ Time Frame: 44 weeks ]
- Heart rate variability [ Time Frame: 44 weeks ]
- Flow mediated dilation [ Time Frame: 44 weeks ]
- Pulse wave velocity and augmentation index [ Time Frame: 44 weeks ]
- Blood glucose [ Time Frame: 44 weeks ]HbA1c and oral glucose tolerance test
- Lipids [ Time Frame: 44 weeks ]Total, LDL and HDL cholesterol, triglycerid and ratios
- Body composition [ Time Frame: 44 weeks ]Visceral fat volume and weight, visceral to subcutaneous fat ratio.
- Bone mineral density [ Time Frame: 44 weeks ]Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.
- Body mass index [ Time Frame: 44 weeks ]
- Vitamin D levels [ Time Frame: 44 weeks ]
- Fatty acid composition in plasma and renal tissue [ Time Frame: 44 weeks ]
- Tacrolimus pharmacokinetics [ Time Frame: 12 weeks ]Substudy of 15 patients, where we study tacrolimus trough levels, Tmax and AUC at the end of the ORENTRA trial, after a minimum of 4 weeks wash-out and again after 4 weeks of 2.7 g omega-3 fatty acid supplementation
- Incidence of post-transplant complications [ Time Frame: 44 weeks + 8 weeks ]
- Adverse events [ Time Frame: 44 weeks + 8 weeks ]
- Adverse reactions [ Time Frame: 44 weeks ]
- Frequency of clinically significant safety laboratory variables [ Time Frame: 44 weeks ]Especially INR and tacrolimus trough concentrations. Follow-up by local nephrologist plus five Telephone Controls during follow-up.
- Quality of life [ Time Frame: 44 weeks ]The participants fill out SF-36 at baseline and the 1 year post transplant control for both safety reasons and measurement of differences between the groups with regards to quality of life.
- Food questionnaire [ Time Frame: 44 weeks ]Two specially designed food questionnaires to obtain data on dietary habits in general and type and amount of fish consumed
- Comorbidity, concomitant medication and life-style factor interview [ Time Frame: 44 weeks ]
|Study Start Date:||November 2013|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Omega-3 fatty acids
2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks.
Drug: Omega-3 fatty acids
2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
Other Name: Omacor
Placebo Comparator: Placebo
Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
Placebo capsules 3 times a day (oral administration)
Other Name: Olive oil
There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.
8 weeks after transplantation, if renal function has stabilized, patients with a eGFR>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744067
|Oslo University Hospital Rikshospitalet|
|Oslo, * Other, Norway, 0424|
|Oslo University Hospital, Rikshospitalet|
|Oslo, Norway, 0027|
|Principal Investigator:||Ivar A Eide, MD||Oslo University Hospital|