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Trial record 47 of 179 for:    Phospholipids

Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival

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ClinicalTrials.gov Identifier: NCT02017990
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : March 3, 2014
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital

Brief 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.

Condition or disease
Disorder of Transplanted Kidney

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.

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Study Type : Observational
Actual Enrollment : 2002 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : October 1999
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Renal transplant recipients
No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood.



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to 12 years. ]
    First patient recruited October 1999 and all remaining patients were censored at August 2012.


Secondary Outcome Measures :
  1. Loss of function in the renal transplant. [ Time Frame: Up to 12 years. ]
    As for primary endpoint.


Other Outcome Measures:
  1. Cause specific mortality rates. [ Time Frame: Up to 12 years. ]
    As for the primary endpoint. Mortality rates for cardiac, cerebrovascular, infectious disease and malignancies.

  2. Cause specific graft loss. [ Time Frame: Up to 12 years. ]
    As for the primary endpoints. Graft loss rates for rejection and recurrence as well as total and death censored graft loss will be registered.

  3. Rejection rate. [ Time Frame: Up to 12 years. ]
    As for the primary endpoint.


Biospecimen Retention:   Samples Without DNA
Plasma phospholipids.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal transplant recipients
Criteria

Inclusion Criteria:

  • Received a renal transplant. Signed informed consent.

Exclusion Criteria:

  • Under the age of 16 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017990


Locations
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Norway
Oslo University Hospital, Rikshospitalet
Oslo, * Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
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Principal Investigator: Ivar Eide, MD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02017990     History of Changes
Other Study ID Numbers: REK 2012/1419
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Oslo University Hospital:
Renal transplantation
n-3 polyunsaturated fatty acids
Mortality
Graft loss
Rejection