The Effects of Omega-3 Fatty Acids in Renal Transplantation

Phase 4

Completed

• Conditions: Disorder Related to Renal Transplantation
• Interventions: Drug: Placebo; Drug: Omega-3 fatty acids

• Registration Number: NCT01744067
• Lead Sponsor: Oslo University Hospital

Brief Summary

Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-11
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-06
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR>30 ml/min. Signed informed consent.

Read More

Exclusion Criteria

• Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor >75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
Omega-3 fatty acids	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.

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	44 weeks	Iohexol clearance

Secondary Outcome Measures

Name	Time	Method
Proteinuria	44 weeks	Both ACR and FEPR
Inflammation in the renal transplant	44 weeks	Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.
Fibrosis in the renal transplant	44 weeks	As for inflammation
Blood pressure	44 weeks
Lipids	44 weeks	Total, LDL and HDL cholesterol, triglycerid and ratios
Body composition	44 weeks	Visceral fat volume and weight, visceral to subcutaneous fat ratio.
Body mass index	44 weeks
Fatty acid composition in plasma and renal tissue	44 weeks
Heart rate variability	44 weeks
Flow mediated dilation	44 weeks
Bone mineral density	44 weeks	Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.
Vitamin D levels	44 weeks
Tacrolimus pharmacokinetics	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
Pulse wave velocity and augmentation index	44 weeks
Blood glucose	44 weeks	HbA1c and oral glucose tolerance test

Trial Locations

Locations (2)

Oslo University Hospital Rikshospitalet; 🇳🇴 Oslo, * Other, Norway

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway