Pre-emptive Kidney Transplantation Quality of Life

Completed

• Conditions: Kidney Transplantation; Renal Insuffiency

• Registration Number: NCT02154815
• Lead Sponsor: Nantes University Hospital

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.

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 Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Study Start: 2014-09
• Primary Completion: 2018-09
• Study Completion: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in quality of life	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

Secondary Outcome Measures

Name	Time	Method
Anxiety and depressive disorders	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)
Perceived stress	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
Post-transplantation time to return to work	24 month
Evolution of daily proteinuria level	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
Evolution of the Graft Filtration Rate	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
Compliance of patients	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
Posttraumatic growth	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)
KTFS (Kidney Transplant Failure Score )	12 month	The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT.
Generic quality of life	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.
Subjective well-being	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)
Coping strategies	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

Trial Locations

Locations (5)

CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN; 🇫🇷 Nantes, France

CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique; 🇫🇷 Lyon, France

CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie; 🇫🇷 Toulouse, France

CHU MARSEILLE - Hôpital de la Conception - Santé Publique; 🇫🇷 Marseille, France

CHU NICE - Service de Néphrologie; 🇫🇷 Nice, France