The effects of omega-3 fatty acids on the kidney, heart and vascular system in patients who has received a kidney transplant

Conditions: Renal transplantation
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2012-004992-37-NO

Lead Sponsor: South-Eastern Norway Regional Health Authority

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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.
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

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 drugs containing n-3 polyunsaturated fatty acids.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n-3 polyunsatturated fatty acids compared to placebo.;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.;Primary end point(s): The primary end point is glomerular filtration at 12 months.;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 Measures

Name	Time	Method
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.