Disorder of Transplanted KidneyNCT02017990
Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival
An observational study of Disorder of Transplanted Kidney, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Disorder of Transplanted Kidney
- How many people
- 2,002 participants
- Where
- 1 siteNorway
- Study dates
- Oct 1999to Jun 2013
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Renal transplant recipients
Who may be able to join
- Received a renal transplant. Signed informed consent.
Who cannot join
- Under the age of 16 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Levels of Marine n-3 Polyunsaturated Fatty Acids in Plasma Phospholipids as a Prognostic Marker of Mortality and Graft Loss Endpoints in Renal Transplant Recipients.
This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.
Read the detailed description
This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.
- Conditions
- Disorder of Transplanted Kidney
- Keywords
- Renal transplantation, n-3 polyunsaturated fatty acids, Mortality, Graft loss, Rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant recipients | No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
First patient recruited October 1999 and all remaining patients were censored at August 2012.
Measured: Up to 12 years.
Secondary outcomes (1)
Loss of function in the renal transplant.
As for primary endpoint.
Measured: Up to 12 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 1999
- Primary completionAug 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Transplanted KidneyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Ivar Eide, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017990
- Sponsor's protocol ID
- REK 2012/1419
- Status last verified
- Feb 2014
- First submitted
- 17 Dec 2013
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eide IA, Jenssen T, Hartmann A, Diep LM, Dahle DO, Reisaeter AV, Bjerve KS, Christensen JH, Schmidt EB, Svensson M. The association between marine n-3 polyunsaturated fatty acid levels and survival after renal transplantation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1246-56. doi: 10.2215/CJN.11931214. Epub 2015 Jun 10.
PubMed 26063768
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Levels of Marine n-3 Polyunsaturated Fatty Acids in Plasma Phospholipids as a Prognostic Marker of Mortality and Graft Loss Endpoints in Renal Transplant Recipients.
- ClinicalTrials.gov ID
- NCT02017990
- Acronym / sponsor ID
- REK 2012/1419
- Conditions
- Disorder of Transplanted Kidney
- Keywords
- Renal transplantation, n-3 polyunsaturated fatty acids, Mortality, Graft loss, Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,002 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Oct 1999
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Dec 2013 (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 study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.
Detailed description
This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal transplant recipients | – | –No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Renal transplant recipients
Key inclusion criteria (1 listed)
- Received a renal transplant. Signed informed consent.
Key exclusion criteria (1 listed)
- Under the age of 16 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: Up to 12 years.
First patient recruited October 1999 and all remaining patients were censored at August 2012.
1 secondary outcome
Loss of function in the renal transplant.
Time frame: Up to 12 years.
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 Mar 2014.
- Derived from this study: PubMed 26063768Eide IA, Jenssen T, Hartmann A, Diep LM, Dahle DO, Reisaeter AV, Bjerve KS, Christensen JH, Schmidt EB, Svensson M. The association between marine n-3 polyunsaturated fatty acid levels and survival after renal transplantation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1246-56. doi: 10.2215/CJN.11931214. Epub 2015 Jun 10.
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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 Eide, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Transplanted Kidney, run by Oslo University Hospital at 1 site 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
All-cause mortality (time frame: Up to 12 years.). 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 NCT02017990, which also lists 1 linked publication.
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 Mar 2014.