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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02017990

Enrollment

2002

Registered

2013-12-23

Start date

1999-10-31

Completion date

2013-06-30

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Transplanted Kidney

Keywords

Renal transplantation, n-3 polyunsaturated fatty acids, Mortality, Graft loss, Rejection

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Received a renal transplant. Signed informed consent.

Exclusion criteria

* Under the age of 16 years.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Norway

Outcome results