The Effects of Omega-3 Fatty Acids in Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

— ORENTRA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744067
• Other study ID #: 2012/1419
• Secondary ID: 2012-004992-3720
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2012
• Last updated: December 6, 2015
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation

Intervention

Drug:
• Omega-3 fatty acids
2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
• Placebo
Placebo capsules 3 times a day (oral administration)

Locations

Country	Name	City	State
Norway	Oslo University Hospital Rikshospitalet	Oslo	* Other
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Aalborg Universitetshospital, Aarhus University Hospital, Pronova BioPharma, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of post-transplant complications		44 weeks + 8 weeks	Yes
Other	Adverse events		44 weeks + 8 weeks	Yes
Other	Adverse reactions		44 weeks	Yes
Other	Frequency of clinically significant safety laboratory variables	Especially INR and tacrolimus trough concentrations. Follow-up by local nephrologist plus five Telephone Controls during follow-up.	44 weeks	Yes
Other	Quality of life	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.	44 weeks	Yes
Other	Food questionnaire	Two specially designed food questionnaires to obtain data on dietary habits in general and type and amount of fish consumed	44 weeks	No
Other	Comorbidity, concomitant medication and life-style factor interview		44 weeks	No
Primary	Glomerular filtration rate	Iohexol clearance	44 weeks	No
Secondary	Proteinuria	Both ACR and FEPR	44 weeks	No
Secondary	Inflammation in the renal transplant	Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.	44 weeks	No
Secondary	Fibrosis in the renal transplant	As for inflammation	44 weeks	No
Secondary	Blood pressure		44 weeks	No
Secondary	Heart rate variability		44 weeks	No
Secondary	Flow mediated dilation		44 weeks	No
Secondary	Pulse wave velocity and augmentation index		44 weeks	No
Secondary	Blood glucose	HbA1c and oral glucose tolerance test	44 weeks	No
Secondary	Lipids	Total, LDL and HDL cholesterol, triglycerid and ratios	44 weeks	No
Secondary	Body composition	Visceral fat volume and weight, visceral to subcutaneous fat ratio.	44 weeks	No
Secondary	Bone mineral density	Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.	44 weeks	No
Secondary	Body mass index		44 weeks	No
Secondary	Vitamin D levels		44 weeks	No
Secondary	Fatty acid composition in plasma and renal tissue		44 weeks	No
Secondary	Tacrolimus pharmacokinetics	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	12 weeks	Yes