The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant recipients: a randomized double blinded placebo controlled intervention study.

INTERVENTION: Trade Name: Omacor, capsule, soft. Product Name: Omacor Product Code: NA Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: Renal transplantation Therapeutic area: Body processes [G] ‐ Immune system processes [G12] PRIMARY OUTCOME: Main Objective: To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n‐3 polyunsatturated fatty acids compared to placebo. Primary end point(s): The primary end point is glomerular filtration at 12 months. Secondary Objective: To study the degree of proteinuria, inflammation and fibrosis in the kidney transplant, blood pressure, heart rate variability, intima media thickness, pulse wave velocity, flow mediated dilation, b‐HbA1c, lipids and inflammatory markers in kidney transplant recipients receiving supplementation of n‐3 polyunsatturated fatty acids compared to placebo. Timepoint(s) of evaluation of this end point: Baseline is 8 weeks posttransplant where the participants start to take either omega‐3 supplements or placebo. 1 year post transplant they return to undergo the same examinations and end the intervention. SECONDARY OUTCOME: Secondary end point(s): The degree of inflammation and fibrosis in kidney transplant biopsies. Proteinuria. Graft rejections. Inflammation markers. Blood pressure. Heart rate variability. Intima media thickness. Pulse wave velocity. Flow mediated dilation. HbA1c. Lipid and lipoprotein concentrations. Timepoint(s) of evaluation of this end point: Baseline is 8 weeks posttransplant where the participants start to take either omega‐3 supplements or placebo. 1 year post transplant they return to undergo the same examinations and end the intervention. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22