The long-term effect of marine omega-3 fatty acid supplementation in renal transplantatio

Phase 1

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

• Registration Number: EUCTR2016-003537-18-NO
• Lead Sponsor: Akershus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-09
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

- Renal transplant recipients over 18 years of age.
- Stable renal graft function, defined as eGFR >30 ml/min at the last 2 visits.
- 6–60 months post-transplantation at randomization.
- 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

- Patients who participate in a clinical trial with other investigational drugs.
- Patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug Omacor or drugs or dietary supplements similar to the study drug.
- Any reason why, in the opinion of the Principal Investigator, the patient should not participate - E.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified