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Pre-emptive Kidney Transplantation Quality of Life (PreKiTQoL)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Kidney Transplantation
Renal Insuffiency

Treatments

Other: Questionnaires : Patient-Reported Outcomes

Study type

Observational

Funder types

Other

Identifiers

NCT02154815
RC14_0078

Details and patient eligibility

About

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.

Full 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.

Enrollment

390 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

390 participants in 2 patient groups

PPT
Description:
Patients with a pre-emptive kidney transplantation from deceased or living donors
Treatment:
Other: Questionnaires : Patient-Reported Outcomes
PDT
Description:
Patients who have experienced a pre-transplant dialysis period of less than 36 months
Treatment:
Other: Questionnaires : Patient-Reported Outcomes

Trial contacts and locations

5

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Central trial contact

Emmanuelle PAPUCHON

Data sourced from clinicaltrials.gov

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