Disorder Related to Renal TransplantationPhase 4ORENTRANCT01744067
The Effects of Omega-3 Fatty Acids in Renal Transplantation
A Phase 4 study testing Omega-3 fatty acids in people with Disorder Related to Renal Transplantation, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 4
- 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
- Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR>30 ml/min. Signed informed consent.
Who cannot join
- Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor >75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital Rikshospitalet
Oslo, * Other, 0424
Oslo University Hospital, Rikshospitalet
Oslo, Oslo, 0027
About this study
Official title: The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.
Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
Read the detailed description
There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.
8 weeks after transplantation, if renal function has stabilized, patients with a eGFR>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.
- Being tested
- Omega-3 fatty acids, Placebo
- Keywords
- Renal transplantation, Interventional study, Glomerular filtration rate, Renal function, Proteinuria, Cardiovascular risk markers, Blood pressure, Flow mediated vasodilation, Heart rate variability, Pulse wave velocity, Lipids, Blood glucose, Bone mineral density, Body composition, Fat distribution, Body mass index, Fatty acid composition, Tacrolimus pharmacokinetics, Omega-3 fatty acids, Marine n-3 fatty acids
- Medical subject headings
- Proteinuria, Pulmonary Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDrug
Also called Omacor
2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
PlaceboDrug
Also called Olive oil
Placebo capsules 3 times a day (oral administration)
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acids | Active comparator | 2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks. Receives: Drug: Omega-3 fatty acids |
| Placebo | Placebo comparator | Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Iohexol clearance
Measured: 44 weeks
Secondary outcomes (15)
Proteinuria
Both ACR and FEPR
Measured: 44 weeks
Inflammation in the renal transplant
Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.
Measured: 44 weeks
Fibrosis in the renal transplant
As for inflammation
Measured: 44 weeks
Blood pressure
Measured: 44 weeks
Heart rate variability
Measured: 44 weeks
Flow mediated dilation
Measured: 44 weeks
Pulse wave velocity and augmentation index
Measured: 44 weeks
Blood glucose
HbA1c and oral glucose tolerance test
Measured: 44 weeks
Lipids
Total, LDL and HDL cholesterol, triglycerid and ratios
Measured: 44 weeks
Body composition
Visceral fat volume and weight, visceral to subcutaneous fat ratio.
Measured: 44 weeks
Bone mineral density
Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.
Measured: 44 weeks
Body mass index
Measured: 44 weeks
Vitamin D levels
Measured: 44 weeks
Fatty acid composition in plasma and renal tissue
Measured: 44 weeks
Tacrolimus pharmacokinetics
Substudy of 15 patients, where we study tacrolimus trough levels, Tmax and AUC at the end of the ORENTRA trial, after a minimum of 4 weeks wash-out and again after 4 weeks of 2.7 g omega-3 fatty acid supplementation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Pronova BioPharma, South-Eastern Norway Regional Health Authority, Aalborg University Hospital
- Responsible party
- Principal investigator, Ivar Eide, Oslo University Hospital
- Investigators
- Ivar A Eide, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744067
- Sponsor's protocol ID
- 2012/1419
- Other IDs
- 2012-004992-37, 2012033, 2012/1419
- Acronym
- ORENTRA
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2012
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.
PubMed 34939013Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.
PubMed 30125457
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.
- ClinicalTrials.gov ID
- NCT01744067
- Acronym / sponsor ID
- ORENTRA / 2012/1419
- Keywords
- Renal transplantation, Interventional study, Glomerular filtration rate, Renal function, Proteinuria, Cardiovascular risk markers, Blood pressure, Flow mediated vasodilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Pronova BioPharma, South-Eastern Norway Regional Health Authority, Aalborg University Hospital
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Dec 2012 (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.
Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
Detailed description
There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.
8 weeks after transplantation, if renal function has stabilized, patients with a eGFR>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.
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 |
|---|---|---|
| Omega-3 fatty acids | Active comparator | Drug: Omega-3 fatty acids2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR>30 ml/min. Signed informed consent.
Key exclusion criteria (1 listed)
- Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor >75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.
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 |
|---|---|---|
| Omega-3 fatty acidsAlso: Omacor2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration) | Drug | Omega-3 fatty acids |
| PlaceboAlso: Olive oilPlacebo capsules 3 times a day (oral administration) | Drug | Placebo |
Primary outcome
Glomerular filtration rate
Time frame: 44 weeks
Iohexol clearance
15 secondary outcomes
Proteinuria
Time frame: 44 weeks
Inflammation in the renal transplant
Time frame: 44 weeks
Fibrosis in the renal transplant
Time frame: 44 weeks
Blood pressure
Time frame: 44 weeks
Heart rate variability
Time frame: 44 weeks
Flow mediated dilation
Time frame: 44 weeks
Pulse wave velocity and augmentation index
Time frame: 44 weeks
Blood glucose
Time frame: 44 weeks
Lipids
Time frame: 44 weeks
Body composition
Time frame: 44 weeks
Bone mineral density
Time frame: 44 weeks
Body mass index
Time frame: 44 weeks
Vitamin D levels
Time frame: 44 weeks
Fatty acid composition in plasma and renal tissue
Time frame: 44 weeks
Tacrolimus pharmacokinetics
Time frame: 12 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 8 Dec 2015.
- Derived from this study: PubMed 34939013Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.
- Derived from this study: PubMed 30125457Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.
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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.
Ivar A Eide, MD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 fatty acids in people with Disorder Related to Renal Transplantation, run by Oslo University Hospital at 2 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 1 inclusion and 1 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 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744067, which also lists 2 linked publications.
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 8 Dec 2015.