The Effects of Omega-3 Fatty Acids in Renal Transplantation

NCT01744067 | Completed Phase 4

• 3 other identifiers: 2012/14192012-004992-372012033
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Disorder Related to Renal Transplantation

Keywords

Renal transplantation; Interventional study; Glomerular filtration rate; Renal function; Proteinuria; 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; Fatty acid composition; Tacrolimus pharmacokinetics; Omega-3 fatty acids; Marine n-3 fatty acids; Fatty acids; Gas chromatography; Interstitial fibrosis; Inflammation

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate

  Iohexol clearance

  44 weeks

Secondary Outcomes (15)

• Proteinuria

  44 weeks

• Inflammation in the renal transplant

  44 weeks

• Fibrosis in the renal transplant

  44 weeks

• Blood pressure

  44 weeks

• Heart rate variability

  44 weeks

Other Outcomes (7)

• Incidence of post-transplant complications

  44 weeks + 8 weeks

• Adverse events

  44 weeks + 8 weeks

• Adverse reactions

  44 weeks

Study Arms (2)

Omega-3 fatty acids

ACTIVE COMPARATOR

2,7 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

Placebo

PLACEBO COMPARATOR

Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.

Drug: Placebo

Interventions

Omega-3 fatty acids DRUG

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

Also known as: Omacor

Omega-3 fatty acids

Placebo DRUG

Placebo capsules 3 times a day (oral administration)

Also known as: Olive oil

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Aarhus University Hospital: collaborator
• Pronova BioPharma: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• Aalborg University Hospital: collaborator

Study Sites (2)

Oslo University Hospital Rikshospitalet

Oslo, * Other, 0424, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, 0027, Norway

Location

Related Publications (2)

• Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.

  PMID: 34939013 DERIVED

• Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.

  PMID: 30125457 DERIVED

MeSH Terms

Conditions

Proteinuria; Pulmonary Fibrosis; Inflammation

Interventions

Fatty Acids, Omega-3; Omacor; Olive Oil

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ivar A Eide, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

NO (2)