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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC14_0078

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