E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of oral supplementation of 2.5 g marine n-3 PUFAs / day compared with placebo by the change in estimated glomerular filtration rate (eGFR, by CKD-EPI or MDRD equation) from baseline to after 156 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
The effect of oral supplementation of 2.5 g marine n-3 PUFAs / day compared with placebo on: - The degree of proteinuria. - The difference in plasma inflammatory and fibrotic biomarkers. - The following cardiovascular risk factors: Blood pressure, resting heart rate, fasting serum glucose, HbA1c, lipids and lipoproteins and body mass index.
Associations between the levels of marine n-3 PUFA in plasma phospholipids and changes in eGFR in renal transplant recipients. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Same title, date and version as the main study. Additional investigations on participants from Akershus University Hospital:
The effect of oral supplementation of 2.5 g marine n-3 PUFAs / day compared with placebo on: - Heart rate variability. - The degree of fibrosis in renal graft biopsy samples. - The level of marine n-3 PUFA in the renal graft biopsy samples determined by mass spectrometry.
Associations between the levels of marine n-3 PUFA in plasma phospholipids and the degree of fibrosis detected in renal graft biopsy samples. |
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E.3 | Principal 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. |
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E.4 | Principal exclusion criteria |
- 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in estimated glomerular filtration rate (by CKD-EPI or MDRD equation) after 156 weeks in the treatment group compared with the control group. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 52, 104 and 156 weeks of treatment. |
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E.5.2 | Secondary end point(s) |
Changes in the treatment group compared with the control group for the following variables: - Proteinuria. - Plasma fatty acid levels. - Plasma inflammatory biomarkers. - Plasma fibrotic biomarkers. - Blood pressure - Resting heart rate - Fasting serum glucose / HbA1c. - Lipid and lipoprotein concentrations. - Body mass index. - Number of graft rejections and graft losses. - Number of cardiovascular events and deaths.
Sub-study, participants from Akershus University Hospital only: - Heart rate variability. - The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue. - Markers of fibrosis in renal cortical tissue. - Fatty acid levels in renal cortical tissue.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 156 weeks of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |