Pre-emptive Kidney Transplantation Quality of Life

Kidney Transplantation Clinical Trial

— PreKiTQoL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02154815
• Other study ID #: RC14_0078
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2014
• Last updated: July 2, 2015
• Start date: September 2014
• Est. completion date: September 2020

Study information

• Verified date: July 2015
• Source: Nantes University Hospital
• Contact: Emmanuelle PAPUCHON
• Phone: 02 40 08 77 82
• Email: emmanuelle.papuchon[@]chu-nantes.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: September 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation
• Renal Insuffiency

Intervention

Other:
• Questionnaires : Patient-Reported Outcomes
Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, and 24 months

Locations

Country	Name	City	State
France	CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique	Lyon
France	CHU MARSEILLE - Hôpital de la Conception - Santé Publique	Marseille
France	CHU MONTPELLIER - Hôpital Lapeyronie - Service de Néphrologie	Montpellier
France	CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN	Nantes
France	CHU NICE - Service de Néphrologie	Nice
France	AP-HP - Hôpital St Louis - Service de Néphrologie et Transplantation Rénale	Paris
France	AP-HP Hopital Necker	Paris
France	CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life	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	every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Generic quality of life	Generic QoL will be assessed with the SF36 every 6 months prior to surgery, at hospital discharge and at three, six, 12, and 24 months, and compared between PPT versus PDT.	every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Anxiety and depressive disorders	Anxiety and depressive disorders will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT using the questionnaire HAD (Hospital Anxiety and Depression scale)	every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Subjective well-being	Subjective well-being will be assessed every six months prior to surgery, at hospital discharge and at three, six, 12, and 24 months, and compared between PPT versus PDT using the satisfaction with life scale (SWLS)	every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Perceived stress	The perceived stress will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT with the Perceived Stress Scale	every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Coping strategies	The coping strategies will be assessed at six and 24 months post transplantation and compared between PPT versus PDT with the Brief Cope	six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Posttraumatic growth	The posttraumatic growth will be assessed at six and 24 months post transplantation and compared between PPT versus PDT with the Posttraumatic Growth Inventory (PTGI)	six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Evolution of the Graft Filtration Rate	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 three, six, 12 and 24-months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula	hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	Evolution of daily proteinuria level	The evolution of the daily proteinuria level will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and three, six, 12 and 24-months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test	hospital discharge, and 3, 6, 12, and 24 months	No
Secondary	KTFS (Kidney Transplant Failure Score )	The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT.	12 month	No
Secondary	Post-transplantation time to return to work		24 month	No
Secondary	Compliance of patients	Compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at three, six, 12, and 24 months, and compared between PPT versus PDT with the Girerd questionnaire	six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months	No

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