Clinical trial NCT03018041: The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
Official title: The Long-term Effect of Marine n-3 Polyunsaturated Fatty Acid Supplementation on Glomerular Filtration Rate and Development of Fibrosis in the Renal Allograft: a Randomized Double Blind Placebo Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Rikshospitalet University Hospital
name: Ullevaal University Hospital
name: Drammen sykehus
name: Elverum Hospital
name: South-Eastern Norway Regional Health Authority
name: Aalborg University Hospital
name: Pronova BioPharma
name: Haukeland University Hospital
name: University Hospital of North Norway
First posted: 2017-01-11
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. Patients will be randomized to oral supplementation of marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.

The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. Secondary endpoints include the following variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate, fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths.

Patients from Akershus University Hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (CADI) and markers of fibrosis.

Eligibility criteria: Inclusion Criteria:

* Renal transplant recipients over 18 years of age.
* Stable renal graft function, defined as eGFR \>30 ml/min at the last 2 visits.
* 6-60 months post-transplantation at randomization.
* Signed informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 156 weeks
Secondary outcomes:
measure: Proteinuria
timeFrame: 156 weeks
measure: Plasma fatty acid levels
timeFrame: 156 weeks
measure: Plasma inflammatory biomarkers
timeFrame: 156 weeks
measure: Blood pressure
timeFrame: 156 weeks
measure: Resting heart rate
timeFrame: 156 weeks
measure: Fasting serum glucose / HbA1c
timeFrame: 156 weeks
measure: Lipid and lipoprotein concentrations
timeFrame: 156 weeks
measure: Body mass index
timeFrame: 156 weeks
measure: Heart rate variability
timeFrame: 156 weeks
measure: The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue
timeFrame: 156 weeks
measure: Markers of fibrosis in renal cortical tissue
timeFrame: 156 weeks
measure: Fatty acid levels in renal cortical tissue
timeFrame: 156 weeks
Other outcomes:
measure: Adverse events
timeFrame: 156 weeks
measure: Adverse reactions
timeFrame: 156 weeks
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Drammen
country: Norway
facility: Drammen Hospital
state: Buskerud
city: Elverum
country: Norway
facility: Elverum Hospital
state: Hedmark
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital, Akershus
name: My Svensson, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Akershus
name: Ivar Anders Eide, MD, PhD
role: STUDY_CHAIR
affiliation: Ullevaal University Hospital
name: Branimir Draganov, MD
role: STUDY_CHAIR
affiliation: University Hospital, Akershus
name: Joe Chan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drammen sykehus
name: Morten Reier-Nilsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elverum Hospital
name: Tone Granseth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Nanna von der Lippe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Bård Endre Waldum-Grevbo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Per Olav Rui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Toralf Melsom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Renathe Rismo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: