NCT01744067.

Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double blind (subject, caregiver, investigator, outcomes assessor) Primary purpose: treatment
Participants	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. 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.
Interventions	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. Placebo comparator Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
Outcomes	Primary outcome measures Glomerular filtration rate. Time frame: 44 weeks. Iohexol clearance Secondary outcome measures 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, triglyceride 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 Other outcomes 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.
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