NCT02017990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,002

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

12.8 years

First QC Date

December 17, 2013

Last Update Submit

February 28, 2014

Conditions

Disorder of Transplanted Kidney

Keywords

Renal transplantationn-3 polyunsaturated fatty acidsMortalityGraft lossRejection

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    First patient recruited October 1999 and all remaining patients were censored at August 2012.

    Up to 12 years.

Secondary Outcomes (1)

  • Loss of function in the renal transplant.

    Up to 12 years.

Other Outcomes (3)

  • Cause specific mortality rates.

    Up to 12 years.

  • Cause specific graft loss.

    Up to 12 years.

  • Rejection rate.

    Up to 12 years.

Study Arms (1)

Renal transplant recipients

No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Renal transplant recipients

You may qualify if:

  • Received a renal transplant. Signed informed consent.

You may not qualify if:

  • Under the age of 16 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, 0027, Norway

Location

Related Publications (1)

  • Eide IA, Jenssen T, Hartmann A, Diep LM, Dahle DO, Reisaeter AV, Bjerve KS, Christensen JH, Schmidt EB, Svensson M. The association between marine n-3 polyunsaturated fatty acid levels and survival after renal transplantation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1246-56. doi: 10.2215/CJN.11931214. Epub 2015 Jun 10.

    PMID: 26063768DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma phospholipids.

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Ivar Eide, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

October 1, 1999

Primary Completion

August 1, 2012

Study Completion

June 1, 2013

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

NO(1)