Kidney Transplantation
Conditions
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
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.
Interventions
DRUGOmacor
As described in Arms.
DRUGPlacebo Oral Capsule
As described in Arms.
Sponsors
University of Oslo
Rikshospitalet University Hospital
Ullevaal University Hospital
Drammen sykehus
Elverum Hospital
South-Eastern Norway Regional Health Authority
Aalborg University Hospital
Pronova BioPharma
Haukeland University Hospital
University Hospital of North Norway
Joe Chan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular filtration rate | 156 weeks | Estimated by CKD-EPI equation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria | 156 weeks | ACR and FE-protein |
| Plasma fatty acid levels | 156 weeks | measured by gas chromatography |
| Plasma inflammatory biomarkers | 156 weeks | — |
| Blood pressure | 156 weeks | — |
| Resting heart rate | 156 weeks | — |
| Fasting serum glucose / HbA1c | 156 weeks | — |
| Markers of fibrosis in renal cortical tissue | 156 weeks | Sub-study, participants from Akershus University Hospital only |
| Fatty acid levels in renal cortical tissue | 156 weeks | Sub-study, participants from Akershus University Hospital only |
| Lipid and lipoprotein concentrations | 156 weeks | — |
| Body mass index | 156 weeks | — |
| Heart rate variability | 156 weeks | Sub-study, participants from Akershus University Hospital only |
| The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue | 156 weeks | Sub-study, participants from Akershus University Hospital only |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 156 weeks | Incl. number of graft rejections and losses, cardiovascular events and deaths |
| Adverse reactions | 156 weeks | — |
Countries
Norway
Outcome results
None listed