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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oslo University Hospital
Sponsor:
Collaborators:
Aarhus University Hospital
Pronova BioPharma
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Ivar Eide, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01744067
First received: December 4, 2012
Last updated: November 21, 2013
Last verified: November 2013
  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 ]
    Difference between treatment and control group with regards to glomerular filtration rate, measured by iohexol concentrations.


Secondary Outcome Measures:
  • Proteinuria [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to proteinuria (ACR and FEPR).

  • Inflammation in the renal transplant [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to the degree of inflammation in renal transplant biopsies.

  • Fibrosis in the renal transplant [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to fibrosis in renal transplant biopsies.

  • Blood pressure [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to systolic and diastolic blood pressure and number of antihypertensive drugs.

  • Heart rate variability [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to heart rate variability.

  • Flow mediated dilation [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to flow mediated vasodilation.

  • Pulse wave velocity [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to pulse wave velocity.

  • Blood glucose [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to HbA1c and oral glucose tolerance test.

  • Lipids [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to change of total cholesterol, triglyceride, LDL and HDL concentrations and ratios.

  • Body composition [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to change in body composition, especially visceral fat volume and weight.

  • Bone mineral density [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to bone mineral density in the lumbar spine, hips, femur and arms.

  • Waist circumference [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to waist circumference

  • Body mass index [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to BMI.

  • Vitamin D levels [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to vitamin D levels.

  • Fatty acid composition in renal tissue and validation of food questionary [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Difference between treatment and control group with regards to fatty acid composition in plasma phospholipids and renal transplant biopsies. This information will also be used to validate a questionary focusing on intake of fish and seafood developed for this study.


Other Outcome Measures:
  • Incidence of post-transplant complications [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Incidence of post-transplant complications as a measurement of safety.

  • Adverse events [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Incidence of adverse events as a measurement of safety.

  • Adverse reactions [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Incidence of adverse reactions as a measurement of safety.

  • Frequency of clinically significant safety laboratory variables [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Frequency of clinically significant safety laboratory variables as a measurement of safety.

  • 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.


Estimated Enrollment: 132
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3 fatty acids
2,5 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
2,5 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 140 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 2,5 g of omega-3 fatty acids (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

Contacts
Contact: Ivar A Eide, MD +47 92052285 ivaeid@ous-hf.no

Locations
Norway
Oslo University Hospital Rikshospitalet Recruiting
Oslo, * Other, Norway, 0424
Contact: Ivar Eide, MD    4792052285    ivar.anders.eide@gmail.com   
Contact: Trond Jenssen, PhD    4723070000    tjenssen@ous-hf.no   
Principal Investigator: Ivar Eide, MD         
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0027
Contact: Ivar A Eide, MD    +47 92052285    ivaeid@ous-hf.no   
Principal Investigator: Ivar A Eide, MD         
Sponsors and Collaborators
Oslo University Hospital
Aarhus University Hospital
Pronova BioPharma
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Ivar A Eide, MD Oslo University Hospital
  More Information

No publications provided

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: November 21, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Omega-3 fatty acids
n-3 polyunsaturated fatty acids
End stage chronic kidney failure
Renal transplantation
Interventional study
Glomerular filtration rate
Renal function
Proteinuria
Albuminuria
Renal transplant inflammation
Renal transplant fibrosis
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
Waist circumference
Fatty acid composition
Food questionary

ClinicalTrials.gov processed this record on October 19, 2014