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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 December 2023 |
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Main ID: |
NCT03018041 |
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Date of registration:
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10/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
EMiRA |
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Scientific title:
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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 |
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Date of first enrolment:
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September 1, 2017 |
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Target sample size:
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174 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03018041 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Norway
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Contacts
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Name:
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Joe Chan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Akershus |
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Name:
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Branimir Draganov, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ullevaal University Hospital |
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Name:
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Per Olav Rui, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haukeland University Hospital |
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Name:
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My Svensson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Akershus |
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Name:
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Morten Reier-Nilsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Drammen sykehus |
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Name:
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Renathe Rismo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of North Norway |
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Name:
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Tone Granseth, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Elverum Hospital |
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Name:
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Bård Endre Waldum-Grevbo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ullevaal University Hospital |
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Name:
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Nanna von der Lippe, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ullevaal University Hospital |
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Name:
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Toralf Melsom, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of North Norway |
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Name:
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Ivar Anders Eide, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Akershus |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Kidney Transplantation
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Intervention(s)
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Drug: Placebo Oral Capsule
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Drug: Omacor
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Primary Outcome(s)
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Glomerular filtration rate
[Time Frame: 156 weeks]
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Secondary Outcome(s)
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Markers of fibrosis in renal cortical tissue
[Time Frame: 156 weeks]
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Plasma inflammatory biomarkers
[Time Frame: 156 weeks]
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Blood pressure
[Time Frame: 156 weeks]
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Body mass index
[Time Frame: 156 weeks]
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Lipid and lipoprotein concentrations
[Time Frame: 156 weeks]
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Resting heart rate
[Time Frame: 156 weeks]
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Fasting serum glucose / HbA1c
[Time Frame: 156 weeks]
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Proteinuria
[Time Frame: 156 weeks]
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Fatty acid levels in renal cortical tissue
[Time Frame: 156 weeks]
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The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue
[Time Frame: 156 weeks]
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Heart rate variability
[Time Frame: 156 weeks]
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Plasma fatty acid levels
[Time Frame: 156 weeks]
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Secondary ID(s)
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2016-003537-18
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2016/1652 (REK)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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