The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation

NCT03018041 | Completed Phase 3

• 2 other identifiers: 2016/1652 (REK)2016-003537-18
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 6

Brief Summary

This is a long-term intervention study on the effects of marine n-3 PUFAs in renal transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation will have less decline in kidney transplant function compared to patients treated with placebo.

Conditions

Kidney Transplantation

Keywords

Kidney transplantation; Renal transplantation; Omega-3 fatty acids; Marine n-3 fatty acids; Fatty acids; Inflammation; Interstitial fibrosis; Glomerular filtration rate; Renal function; Allograft function; Proteinuria; Blood pressure; Heart rate variability; Lipids; Blood glucose; Body mass index; Fatty acid composition; Gas chromatography; Interventional study; Allograft biopsy; Kidney biopsy

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate

  Estimated by CKD-EPI equation

  156 weeks

Secondary Outcomes (12)

• Proteinuria

  156 weeks

• Plasma fatty acid levels

  156 weeks

• Plasma inflammatory biomarkers

  156 weeks

• Blood pressure

  156 weeks

• Resting heart rate

  156 weeks

Other Outcomes (2)

• Adverse events

  156 weeks

• Adverse reactions

  156 weeks

Study Arms (2)

Marine n-3 PUFAs

EXPERIMENTAL

3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).

Drug: Omacor

Placebo

PLACEBO COMPARATOR

Corresponding placebo oral capsules with olive oil, three capsules daily.

Drug: Placebo Oral Capsule

Interventions

Omacor DRUG

As described in "Arms".

Also known as: Omega-3 fatty acids, EPA, DHA, Marine n-3 polyunsaturated fatty acids

Marine n-3 PUFAs

Placebo Oral Capsule DRUG

As described in "Arms".

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:

• Renal transplant recipients over 18 years of age.
• Stable renal graft function, defined as eGFR \>30 ml/min at the last 2 visits.
• months post-transplantation at randomization.
• Signed informed consent.

You may not qualify if:

• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
• Women who are pregnant or breastfeeding.
• Patients who participate in a clinical trial with other investigational drugs.
• Patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug Omacor or drugs or dietary supplements similar to the study drug.
• Any reason why, in the opinion of the Principal Investigator, the patient should not participate - E.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.

Sponsors & Collaborators

• Joe Chan: lead
• University of Oslo: collaborator
• Rikshospitalet University Hospital: collaborator
• Ullevaal University Hospital: collaborator
• Drammen sykehus: collaborator
• Elverum Hospital: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• Aalborg University Hospital: collaborator
• Pronova BioPharma: collaborator
• Haukeland University Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (6)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Drammen Hospital

Drammen, Buskerud, 3004, Norway

Location

Elverum Hospital

Elverum, Hedmark, 2409, Norway

Location

Ullevaal University Hospital

Oslo, Oslo County, 0450, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

MeSH Terms

Conditions

Inflammation; Pulmonary Fibrosis; Proteinuria

Interventions

Omacor; Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

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

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

• My Svensson, MD, PhD

  University Hospital, Akershus

  STUDY DIRECTOR

• Ivar Anders Eide, MD, PhD

  University Hospital, Akershus

  STUDY CHAIR

• Branimir Draganov, MD

  Ullevaal University Hospital

  STUDY CHAIR

• Joe Chan, MD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

• Morten Reier-Nilsen, MD

  Drammen sykehus

  PRINCIPAL INVESTIGATOR

• Tone Granseth, MD

  Elverum Hospital

  PRINCIPAL INVESTIGATOR

• Nanna von der Lippe, MD, PhD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

• Bård Endre Waldum-Grevbo, MD, PhD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

• Per Olav Rui, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Toralf Melsom, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Renathe Rismo, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: September 1, 2017
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)