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

Disorder of Transplanted Kidney Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017990
• Other study ID #: REK 2012/1419
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: February 28, 2014
• Start date: October 1999
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2002
• Est. completion date: June 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Received a renal transplant. Signed informed consent.

Exclusion Criteria:

• Under the age of 16 years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disorder of Transplanted Kidney

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo	* Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cause specific mortality rates.	As for the primary endpoint. Mortality rates for cardiac, cerebrovascular, infectious disease and malignancies.	Up to 12 years.	No
Other	Cause specific graft loss.	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.	No
Other	Rejection rate.	As for the primary endpoint.	Up to 12 years.	No
Primary	All-cause mortality	First patient recruited October 1999 and all remaining patients were censored at August 2012.	Up to 12 years.	No
Secondary	Loss of function in the renal transplant.	As for primary endpoint.	Up to 12 years.	No