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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
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

December 4, 2012
December 6, 2012
December 8, 2015
November 2013
December 2015   (Final data collection date for primary outcome measure)
Glomerular filtration rate [ Time Frame: 44 weeks ]
Iohexol clearance
Glomerular filtration rate [ Time Frame: 44 weeks ]
Difference in change of glomerular filtration rate from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
Complete list of historical versions of study NCT01744067 on ClinicalTrials.gov Archive Site
  • Proteinuria [ Time Frame: 44 weeks ]
    Both ACR and FEPR
  • 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.
  • Fibrosis in the renal transplant [ Time Frame: 44 weeks ]
    As for inflammation
  • Blood pressure [ Time Frame: 44 weeks ]
  • Heart rate variability [ Time Frame: 44 weeks ]
  • Flow mediated dilation [ Time Frame: 44 weeks ]
  • Pulse wave velocity and augmentation index [ Time Frame: 44 weeks ]
  • Blood glucose [ Time Frame: 44 weeks ]
    HbA1c and oral glucose tolerance test
  • Lipids [ Time Frame: 44 weeks ]
    Total, LDL and HDL cholesterol, triglycerid and ratios
  • Body composition [ Time Frame: 44 weeks ]
    Visceral fat volume and weight, visceral to subcutaneous fat ratio.
  • Bone mineral density [ Time Frame: 44 weeks ]
    Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.
  • Body mass index [ Time Frame: 44 weeks ]
  • Vitamin D levels [ Time Frame: 44 weeks ]
  • Fatty acid composition in plasma and renal tissue [ Time Frame: 44 weeks ]
  • 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
  • Proteinuria [ Time Frame: 44 weeks ]
    Difference in change of proteinuria from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Inflammation in the renal transplant [ Time Frame: 44 weeks ]
    Difference in the degree of inflammation in the renal transplant from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Fibrosis in the renal transplant [ Time Frame: 44 weeks ]
    Difference in the degree of fibrosis in the renal transplant from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Blood pressure [ Time Frame: 44 weeks ]
    Difference in change of blood pressure from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Heart rate variability [ Time Frame: 44 weeks ]
    Difference in change of heart rate variability from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Flow mediated dilation [ Time Frame: 44 weeks ]
    Difference in change of flow mediated vasodilation from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Pulse wave velocity [ Time Frame: 44 weeks ]
    Difference in change in pulse wave velocity from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Inflammation markers [ Time Frame: 44 weeks ]
    Difference in change of inflammatory markers from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Blood glucose [ Time Frame: 44 weeks ]
    Difference in change of HbA1c and oral glucose tolerance test from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Lipids [ Time Frame: 44 weeks ]
    Difference in change of total cholesterol, triglyceride, LDL and HDL concentrations and ratios from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.
  • Incidence of post-transplant complications [ Time Frame: 44 weeks + 8 weeks ]
  • Adverse events [ Time Frame: 44 weeks + 8 weeks ]
  • Adverse reactions [ Time Frame: 44 weeks ]
  • 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.
  • 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.
  • 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
  • Comorbidity, concomitant medication and life-style factor interview [ Time Frame: 44 weeks ]
  • Incidence of post-transplant complications [ Time Frame: 44 weeks ]
    Incidence of post-transplant complications as a measurement of safety.
  • Adverse events [ Time Frame: 44 weeks ]
    Incidence of adverse events as a measurement of safety.
  • Adverse reactions [ Time Frame: 44 weeks ]
    Incidence of adverse reactions as a measurement of safety.
  • Frequency of clinically significant safety laboratory variables [ Time Frame: 44 weeks ]
    Frequency of clinically significant safety laboratory variables as a measurement of safety.
 
The Effects of Omega-3 Fatty Acids in Renal Transplantation
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.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Disorder Related to Renal Transplantation
  • Drug: Omega-3 fatty acids
    2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
    Other Name: Omacor
  • Drug: Placebo
    Placebo capsules 3 times a day (oral administration)
    Other Name: Olive oil
  • 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.
    Intervention: Drug: Omega-3 fatty acids
  • Placebo Comparator: Placebo
    Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01744067
2012/1419
2012-004992-37 ( EudraCT Number )
2012033 ( Other Grant/Funding Number: Norway: Regional Health Authority )
2012/1419 ( Other Identifier: Norway: REK )
No
Not Provided
Not Provided
Ivar Eide, Oslo University Hospital
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
Oslo University Hospital
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP