Pre-emptive Kidney Transplantation Quality of Life (PreKiTQoL)

August 23, 2024 updated by: Nantes University Hospital

Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique
      • Marseille, France, 13005
        • CHU MARSEILLE - Hôpital de la Conception - Santé Publique
      • Nantes, France, 44093
        • CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN
      • Nice, France, 06002
        • CHU NICE - Service de Néphrologie
      • Toulouse, France, 61059
        • CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients waiting a kidney transplantation

Description

Inclusion Criteria:

  • Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center).
  • Only first and single kidney transplantation will be considered.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PPT
Patients with a pre-emptive kidney transplantation from deceased or living donors
Other: Questionnaires : Patient-Reported Outcomes
Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months
PDT
Patients who have experienced a pre-transplant dialysis period of less than 36 months
Other: Questionnaires : Patient-Reported Outcomes
Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: through study completion, an average of 5 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
KTFS (Kidney Transplant Failure Score )
Time Frame: 12 month
The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT.
12 month
Post-transplantation time to return to work
Time Frame: 24 month
24 month
Generic quality of life
Time Frame: through study completion, an average of 5 years
Generic QoL will be assessed with the SF36 every 6 months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT.
through study completion, an average of 5 years
Anxiety and depressive disorders
Time Frame: through study completion, an average of 5 years
Anxiety and depressive disorders will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the questionnaire HAD (Hospital Anxiety and Depression scale)
through study completion, an average of 5 years
Subjective well-being
Time Frame: through study completion, an average of 5 years
Subjective well-being will be assessed every six months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the satisfaction with life scale (SWLS)
through study completion, an average of 5 years
Perceived stress
Time Frame: through study completion, an average of 5 years
The perceived stress will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Perceived Stress Scale
through study completion, an average of 5 years
Coping strategies
Time Frame: through study completion, an average of 5 years
The coping strategies will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Brief Cope
through study completion, an average of 5 years
Posttraumatic growth
Time Frame: through study completion, an average of 5 years
The posttraumatic growth will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Posttraumatic Growth Inventory (PTGI)
through study completion, an average of 5 years
Evolution of the Graft Filtration Rate
Time Frame: through study completion, an average of 5 years
The evolution of the Graft Filtration Rate (GFR) will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and 3, 6,12, 24, 36, 48, 72 months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula
through study completion, an average of 5 years
Evolution of daily proteinuria level
Time Frame: through study completion, an average of 5 years
The evolution of the daily proteinuria level will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and 3, 6,12, 24, 36, 48, 72 months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test
through study completion, an average of 5 years
Compliance of patients
Time Frame: through study completion, an average of 5 years
Compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Girerd questionnaire
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Director: Véronique SEBILLE, Nantes University Hospital
  • Principal Investigator: Aurélie MEURETTE, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

July 25, 2024

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimated)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC14_0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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