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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003537-18 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Rikshospitalet University Hospital | OTHER |
| Ullevaal University Hospital | OTHER |
| Drammen sykehus |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Placebo Comparator | Corresponding placebo oral capsules with olive oil, three capsules daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor | Drug | As described in "Arms". |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate | Estimated by CKD-EPI equation | 156 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria | ACR and FE-protein | 156 weeks |
| Plasma fatty acid levels | measured by gas chromatography | 156 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incl. number of graft rejections and losses, cardiovascular events and deaths | 156 weeks |
| Adverse reactions | 156 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| BÃ¥rd Endre Waldum-Grevbo, MD, PhD | Ullevaal University Hospital | Principal Investigator |
| Per Olav Rui, MD | Haukeland University Hospital | Principal Investigator |
| Toralf Melsom, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | 1478 | Norway | ||
| Drammen Hospital |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D011658 | Pulmonary Fibrosis |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D015525 | Fatty Acids, Omega-3 |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| OTHER |
| Elverum Hospital | UNKNOWN |
| South-Eastern Norway Regional Health Authority | OTHER |
| Aalborg University Hospital | OTHER |
| Pronova BioPharma | INDUSTRY |
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
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| Placebo Oral Capsule | Drug | As described in "Arms". |
|
|
| Plasma inflammatory biomarkers | 156 weeks |
| Blood pressure | 156 weeks |
| Resting heart rate | 156 weeks |
| Fasting serum glucose / HbA1c | 156 weeks |
| Lipid and lipoprotein concentrations | 156 weeks |
| Body mass index | 156 weeks |
| Heart rate variability | Sub-study, participants from Akershus University Hospital only | 156 weeks |
| The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue | Sub-study, participants from Akershus University Hospital only | 156 weeks |
| Markers of fibrosis in renal cortical tissue | Sub-study, participants from Akershus University Hospital only | 156 weeks |
| Fatty acid levels in renal cortical tissue | Sub-study, participants from Akershus University Hospital only | 156 weeks |
| University Hospital of North Norway |
| Principal Investigator |
| Renathe Rismo, MD, PhD | University Hospital of North Norway | Principal Investigator |
| Drammen |
| Buskerud |
| 3004 |
| Norway |
| Elverum Hospital | Elverum | Hedmark | 2409 | Norway |
| Ullevaal University Hospital | Oslo | Oslo | 0450 | Norway |
| Haukeland University Hospital | Bergen | 5021 | Norway |
| University Hospital of North Norway | Tromsø | Norway |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |