Clinical trial NCT01744067: The Effects of Omega-3 Fatty Acids in Renal Transplantation
Official title: The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorder Related to Renal Transplantation
Keywords: Renal transplantation
Interventional study
Glomerular filtration rate
Renal function
Proteinuria
Cardiovascular risk markers
Blood pressure
Flow mediated vasodilation
Heart rate variability
Pulse wave velocity
Lipids
Blood glucose
Bone mineral density
Body composition
Fat distribution
Body mass index
Fatty acid composition
Tacrolimus pharmacokinetics
Omega-3 fatty acids
Marine n-3 fatty acids
Fatty acids
Gas chromatography
Interstitial fibrosis
Inflammation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Pronova BioPharma
name: South-Eastern Norway Regional Health Authority
name: Aalborg University Hospital
First posted: 2012-12-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 44 weeks
Secondary outcomes:
measure: Proteinuria
timeFrame: 44 weeks
measure: Inflammation in the renal transplant
timeFrame: 44 weeks
measure: Fibrosis in the renal transplant
timeFrame: 44 weeks
measure: Blood pressure
timeFrame: 44 weeks
measure: Heart rate variability
timeFrame: 44 weeks
measure: Flow mediated dilation
timeFrame: 44 weeks
measure: Pulse wave velocity and augmentation index
timeFrame: 44 weeks
measure: Blood glucose
timeFrame: 44 weeks
measure: Lipids
timeFrame: 44 weeks
measure: Body composition
timeFrame: 44 weeks
measure: Bone mineral density
timeFrame: 44 weeks
measure: Body mass index
timeFrame: 44 weeks
measure: Vitamin D levels
timeFrame: 44 weeks
measure: Fatty acid composition in plasma and renal tissue
timeFrame: 44 weeks
measure: Tacrolimus pharmacokinetics
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of post-transplant complications
timeFrame: 44 weeks + 8 weeks
measure: Adverse events
timeFrame: 44 weeks + 8 weeks
measure: Adverse reactions
timeFrame: 44 weeks
measure: Frequency of clinically significant safety laboratory variables
timeFrame: 44 weeks
measure: Quality of life
timeFrame: 44 weeks
measure: Food questionnaire
timeFrame: 44 weeks
measure: Comorbidity, concomitant medication and life-style factor interview
timeFrame: 44 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
state: * Other
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Ivar A Eide, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.
citation: Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.