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NCT Number: NCT01744067

The Effects of Omega-3 Fatty Acids in Renal Transplantation

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.

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Key information

Conditions

Disorder Related to Renal Transplantation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Inflammation Lung Diseases Lung Diseases, Interstitial Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Pulmonary Fibrosis Respiratory Tract Diseases Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital Rikshospitalet, Oslo, * Other, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 Fatty acids

Drug

2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)

Other names: Omacor

Placebo

Drug

Placebo capsules 3 times a day (oral administration)

Other names: Olive oil

Primary outcomes

  1. Glomerular filtration rate

    Time frame: 44 weeks

    Iohexol clearance

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Pronova BioPharma
  • South-Eastern Norway Regional Health Authority

Registry information

Official study 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.

Acronym: ORENTRA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2012
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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