The Effects of Omega-3 Fatty Acids in Renal Transplantation - Full Text View

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 Glomerular Filtration Rate, Proteinuria, Fibrosis and Inflammation in the Kidney Transplant and Cardiovascular Risk Markers in Kidney Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Olive oil Omega-3 Fatty Acids

U.S. FDA Resources

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 in change of glomerular filtration rate from baseline 8 weeks after transplantation to 1 year after transplantation between the two treatment groups.

Secondary Outcome Measures:

Proteinuria [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

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.

Estimated Enrollment:	132
Study Start Date:	January 2013
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Omega-3 fatty acids 2 g omega-3 fatty acids / day: Calamarine 1 g 2 capsules by mouth 2 times a day for 44 weeks.	Drug: Omega-3 fatty acids 2 g omega-3 fatty acids / day (2 capsules 2 times a day / oral administration) Other Name: Calamarine
Placebo Comparator: Placebo Placebo: 2 capsules of olive oil by mouth 2 times a day for 44 weeks.	Drug: Placebo Placebo capsules 2 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, when renal functioning usually is stabilized, qualified patients will be randomized to receive either 2 g of omega-3 fatty acids daily or placebo. Baseline measurements will be performed before they start taking the study medication. 1 year after transplantation the same measurements will performed again whereupon the patients stop 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

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	Not yet 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

Pharma Marine

The 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:	December 4, 2012
Health Authority:	Norway: The National Comittees for Medical and Health Research Ethics in Norway. Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:

End stage chronic kidney failure
Renal transplantation
Omega-3 fatty acids
Interventional study
Glomerular filtration rate

Proteinuria
Renal transplant inflammation
Renal transplant fibrosis
Cardiovascular risk markers

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013