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Completed

NCT Number: NCT02017990

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

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.

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Key information

Conditions

Disorder of Transplanted Kidney Behavior Rejection, Psychology Social Behavior

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received a renal transplant. Signed informed consent.

Exclusion criteria

  • Under the age of 16 years.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Loss of function in the renal transplant.

    Time frame: Up to 12 years.

    As for primary endpoint.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study 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.

Important dates

Study start
1999
Primary completion
2012
Study completion
2013
First posted
Dec 23, 2013
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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