Pre-emptive Kidney Transplantation Quality of Life

NCT ID: NCT02154815

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2024-07-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Insuffiency Kidney Transplantation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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PPT

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

Questionnaires : Patient-Reported Outcomes

Intervention Type OTHER

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

Questionnaires : Patient-Reported Outcomes

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique SEBILLE

Role: STUDY_DIRECTOR

Nantes University Hospital

Aurélie MEURETTE

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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

Lyon, , France

Site Status

CHU MARSEILLE - Hôpital de la Conception - Santé Publique

Marseille, , France

Site Status

CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN

Nantes, , France

Site Status

CHU NICE - Service de Néphrologie

Nice, , France

Site Status

CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 26785745 (View on PubMed)

Related Links

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Other Identifiers

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RC14_0078

Identifier Type: -

Identifier Source: org_study_id

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