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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Pronova BioPharma
South-Eastern Norway Regional Health Authority
Aalborg Universitetshospital
Information provided by (Responsible Party):
Ivar Eide, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01744067
First received: December 4, 2012
Last updated: December 6, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Disorder Related to Renal Transplantation
Drug: Omega-3 fatty acids
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Glomerular filtration rate [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Iohexol clearance


Secondary Outcome Measures:
  • Proteinuria [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Both ACR and FEPR

  • Inflammation in the renal transplant [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.

  • Fibrosis in the renal transplant [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    As for inflammation

  • Blood pressure [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Flow mediated dilation [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity and augmentation index [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Blood glucose [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    HbA1c and oral glucose tolerance test

  • Lipids [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Total, LDL and HDL cholesterol, triglycerid and ratios

  • Body composition [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Visceral fat volume and weight, visceral to subcutaneous fat ratio.

  • Bone mineral density [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.

  • Body mass index [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Vitamin D levels [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Fatty acid composition in plasma and renal tissue [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Tacrolimus pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Incidence of post-transplant complications [ Time Frame: 44 weeks + 8 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 44 weeks + 8 weeks ] [ Designated as safety issue: Yes ]
  • Adverse reactions [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of clinically significant safety laboratory variables [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Especially INR and tacrolimus trough concentrations. Follow-up by local nephrologist plus five Telephone Controls during follow-up.

  • Quality of life [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Food questionnaire [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Two specially designed food questionnaires to obtain data on dietary habits in general and type and amount of fish consumed

  • Comorbidity, concomitant medication and life-style factor interview [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: November 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744067

Locations
Norway
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
Investigators
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  2012033  2012/1419 
Study First Received: December 4, 2012
Last Updated: December 6, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
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

ClinicalTrials.gov processed this record on April 27, 2016