NCT02893475

Brief Summary

Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis. The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

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

January 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

August 30, 2016

Last Update Submit

September 2, 2016

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    SF-36 and Retransqol questionnaires

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Societal participation

    through study completion, an average of 1 year

  • Professional reintegration

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population-based

You may qualify if:

  • age \>= 18 years
  • LD kidney transplantation from 2004 through 2009
  • First LD kidney transplantation in the seven most active kidney transplantation centers in France: Paris Necker, Nancy, Paris Saint Louis, Foch, Nantes, Toulouse and Montpellier
  • Patient with a functioning kidney at the time of the study
  • Patient able to read and understand French

You may not qualify if:

  • Patient with multiple transplantation including liver transplantation
  • Patient unable to read and understand French
  • Patient died or lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carole Ayav, MD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share