NCT02154815

Brief Summary

The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

May 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

May 28, 2014

Last Update Submit

August 23, 2024

Conditions

Renal InsuffiencyKidney Transplantation

Keywords

End Stage Renal DiseaseRenal transplantationDialysisPre-emptive transplantationPsychological adjustmentQuality of life.

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life

    The change in quality of life, taking into account psychological adjustment of the patient (response shift). This criterion will be measured by a specifically developed questionnaire : ReTransQol

    through study completion, an average of 5 years

Secondary Outcomes (11)

  • Generic quality of life

    through study completion, an average of 5 years

  • Anxiety and depressive disorders

    through study completion, an average of 5 years

  • Subjective well-being

    through study completion, an average of 5 years

  • Perceived stress

    through study completion, an average of 5 years

  • Coping strategies

    through study completion, an average of 5 years

  • +6 more secondary outcomes

Study Arms (2)

PPT

Patients with a pre-emptive kidney transplantation from deceased or living donors

Other: Questionnaires : Patient-Reported Outcomes

PDT

Patients who have experienced a pre-transplant dialysis period of less than 36 months

Other: Questionnaires : Patient-Reported Outcomes

Interventions

Questionnaires : Patient-Reported OutcomesOTHER

Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months

PDTPPT

Eligibility Criteria

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

Adult patients waiting a kidney transplantation

You may qualify if:

  • Only first and single kidney transplantation will be considered.

You may not qualify if:

  • Re-transplantation or simultaneous transplantation (kidney-pancreas for instance)
  • Patients under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique

Lyon, 69437, France

Location

CHU MARSEILLE - Hôpital de la Conception - Santé Publique

Marseille, 13005, France

Location

CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN

Nantes, 44093, France

Location

CHU NICE - Service de Néphrologie

Nice, 06002, France

Location

CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie

Toulouse, 61059, France

Location

Related Publications (1)

  • Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.

    PMID: 26785745DERIVED

Related Links

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

  • Véronique SEBILLE

    Nantes University Hospital

    STUDY DIRECTOR

  • Aurélie MEURETTE

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 28, 2014

First Posted

June 3, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

July 25, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

FR(5)