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The Effects of Omega-3 Fatty Acids in Renal Transplantation (ORENTRA)

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ClinicalTrials.gov Identifier: NCT01744067
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Drug: Omega-3 fatty acids Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Omega-3 fatty acids
2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
Other Name: Omacor
Placebo Comparator: Placebo
Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
Drug: Placebo
Placebo capsules 3 times a day (oral administration)
Other Name: Olive oil

Outcome Measures

Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 44 weeks ]
    Iohexol clearance

Secondary Outcome Measures :
  1. Proteinuria [ Time Frame: 44 weeks ]
    Both ACR and FEPR

  2. 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.

  3. Fibrosis in the renal transplant [ Time Frame: 44 weeks ]
    As for inflammation

  4. Blood pressure [ Time Frame: 44 weeks ]
  5. Heart rate variability [ Time Frame: 44 weeks ]
  6. Flow mediated dilation [ Time Frame: 44 weeks ]
  7. Pulse wave velocity and augmentation index [ Time Frame: 44 weeks ]
  8. Blood glucose [ Time Frame: 44 weeks ]
    HbA1c and oral glucose tolerance test

  9. Lipids [ Time Frame: 44 weeks ]
    Total, LDL and HDL cholesterol, triglycerid and ratios

  10. Body composition [ Time Frame: 44 weeks ]
    Visceral fat volume and weight, visceral to subcutaneous fat ratio.

  11. Bone mineral density [ Time Frame: 44 weeks ]
    Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.

  12. Body mass index [ Time Frame: 44 weeks ]
  13. Vitamin D levels [ Time Frame: 44 weeks ]
  14. Fatty acid composition in plasma and renal tissue [ Time Frame: 44 weeks ]
  15. 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 Outcome Measures:
  1. Incidence of post-transplant complications [ Time Frame: 44 weeks + 8 weeks ]
  2. Adverse events [ Time Frame: 44 weeks + 8 weeks ]
  3. Adverse reactions [ Time Frame: 44 weeks ]
  4. 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.

  5. 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.

  6. 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

  7. Comorbidity, concomitant medication and life-style factor interview [ Time Frame: 44 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744067

Oslo University Hospital Rikshospitalet
Oslo, * Other, Norway, 0424
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Aarhus University Hospital
Pronova BioPharma
South-Eastern Norway Regional Health Authority
Aalborg Universitetshospital
Principal Investigator: Ivar A Eide, MD Oslo University Hospital
More Information

Responsible Party: Ivar Eide, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01744067     History of Changes
Other Study ID Numbers: 2012/1419
2012-004992-37 ( EudraCT Number )
2012033 ( Other Grant/Funding Number: Norway: Regional Health Authority )
2012/1419 ( Other Identifier: Norway: REK )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Ivar Eide, Oslo University Hospital:
Renal transplantation
Interventional study
Glomerular filtration rate
Renal function
Cardiovascular risk markers
Blood pressure
Flow mediated vasodilation
Heart rate variability
Pulse wave velocity
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