Kidney TransplantationPhase 3EMiRANCT03018041
The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation
A Phase 3 study testing Omacor in people with Kidney Transplantation, run by Joe Chan at 6 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Omacor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 6 sitesNorway
- Study dates
- 1 Sep 2017to 22 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Haukeland University Hospital
Bergen, 5021
Drammen Hospital
Drammen, Buskerud, 3004
Elverum Hospital
Elverum, Hedmark, 2409
Akershus University Hospital
Lørenskog, Akershus, 1478
Ullevaal University Hospital
Oslo, Oslo, 0450
University Hospital of North Norway
Tromsø
About this study
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
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.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- Omacor, Placebo Oral Capsule
- 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
- Medical subject headings
- Inflammation, Pulmonary Fibrosis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmacorDrug
Also called Omega-3 fatty acids, EPA, DHA, Marine n-3 polyunsaturated fatty acids
As described in "Arms".
Placebo Oral CapsuleDrug
Also called Olive oil
As described in "Arms".
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Omacor |
| Placebo | Placebo comparator | Corresponding placebo oral capsules with olive oil, three capsules daily. Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Estimated by CKD-EPI equation
Measured: 156 weeks
Secondary outcomes (12)
Proteinuria
ACR and FE-protein
Measured: 156 weeks
Plasma fatty acid levels
measured by gas chromatography
Measured: 156 weeks
Plasma inflammatory biomarkers
Measured: 156 weeks
Blood pressure
Measured: 156 weeks
Resting heart rate
Measured: 156 weeks
Fasting serum glucose / HbA1c
Measured: 156 weeks
Lipid and lipoprotein concentrations
Measured: 156 weeks
Body mass index
Measured: 156 weeks
Heart rate variability
Sub-study, participants from Akershus University Hospital only
Measured: 156 weeks
The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue
Sub-study, participants from Akershus University Hospital only
Measured: 156 weeks
Markers of fibrosis in renal cortical tissue
Sub-study, participants from Akershus University Hospital only
Measured: 156 weeks
Fatty acid levels in renal cortical tissue
Sub-study, participants from Akershus University Hospital only
Measured: 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Sep 2017
- Primary completion22 Mar 2024
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joe Chan
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Joe Chan, University Hospital, Akershus
- Investigators
- My Svensson, MD, PhD, Study director, University Hospital, AkershusIvar Anders Eide, MD, PhD, Study chair, University Hospital, AkershusBranimir Draganov, MD, Study chair, Ullevaal University HospitalJoe Chan, MD, Principal investigator, University Hospital, AkershusMorten Reier-Nilsen, MD, Principal investigator, Drammen sykehusTone Granseth, MD, Principal investigator, Elverum HospitalNanna von der Lippe, MD, PhD, Principal investigator, Ullevaal University HospitalBård Endre Waldum-Grevbo, MD, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018041
- Sponsor's protocol ID
- 2016/1652 (REK)
- Other IDs
- 2016-003537-18, 2016
- Acronym
- EMiRA
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2017
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03018041
- Acronym / sponsor ID
- EMiRA / 2016/1652 (REK)
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Joe ChanUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marine n-3 PUFAs | Experimental | Drug: Omacor3 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 | Drug: Placebo Oral CapsuleCorresponding placebo oral capsules with olive oil, three capsules daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmacorAlso: Omega-3 fatty acids, EPA, DHA, Marine n-3 polyunsaturated fatty acidsAs described in "Arms". | Drug | Marine n-3 PUFAs |
| Placebo Oral CapsuleAlso: Olive oilAs described in "Arms". | Drug | Placebo |
Primary outcome
Glomerular filtration rate
Time frame: 156 weeks
Estimated by CKD-EPI equation
12 secondary outcomes
Proteinuria
Time frame: 156 weeks
Plasma fatty acid levels
Time frame: 156 weeks
Plasma inflammatory biomarkers
Time frame: 156 weeks
Blood pressure
Time frame: 156 weeks
Resting heart rate
Time frame: 156 weeks
Fasting serum glucose / HbA1c
Time frame: 156 weeks
Lipid and lipoprotein concentrations
Time frame: 156 weeks
Body mass index
Time frame: 156 weeks
Heart rate variability
Time frame: 156 weeks
The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue
Time frame: 156 weeks
Markers of fibrosis in renal cortical tissue
Time frame: 156 weeks
Fatty acid levels in renal cortical tissue
Time frame: 156 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
My Svensson, MD, PhD study director
University Hospital, Akershus
Ivar Anders Eide, MD, PhD study chair
University Hospital, Akershus
Branimir Draganov, MD study chair
Ullevaal University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omacor in people with Kidney Transplantation, run by Joe Chan at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (time frame: 156 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.