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

February 28, 2014 updated by: Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2002

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • * Oslo
      • Oslo, * Oslo, Norway, 0027
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Renal transplant recipients

Description

Inclusion Criteria:

  • Received a renal transplant. Signed informed consent.

Exclusion Criteria:

  • Under the age of 16 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Up to 12 years.
First patient recruited October 1999 and all remaining patients were censored at August 2012.
Up to 12 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of function in the renal transplant.
Time Frame: Up to 12 years.
As for primary endpoint.
Up to 12 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cause specific mortality rates.
Time Frame: Up to 12 years.
As for the primary endpoint. Mortality rates for cardiac, cerebrovascular, infectious disease and malignancies.
Up to 12 years.
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.
Up to 12 years.
Rejection rate.
Time Frame: Up to 12 years.
As for the primary endpoint.
Up to 12 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Ivar Eide, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REK 2012/1419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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