ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-emptive Kidney Transplantation Quality of Life (PreKiTQoL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02154815
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Renal Insuffiency Kidney Transplantation Other: Questionnaires : Patient-Reported Outcomes

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 : Observational
Estimated Enrollment : 390 participants
Time Perspective: Prospective
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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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, and 24 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, and 24 months




Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]

    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 :
  1. Generic quality of life [ Time Frame: every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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.

  2. Anxiety and depressive disorders [ Time Frame: every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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)

  3. Subjective well-being [ Time Frame: every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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)

  4. Perceived stress [ Time Frame: every six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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

  5. Coping strategies [ Time Frame: six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    The coping strategies will be assessed at six and 24 months post transplantation and compared between PPT versus PDT with the Brief Cope

  6. Posttraumatic growth [ Time Frame: six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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)

  7. Evolution of the Graft Filtration Rate [ Time Frame: hospital discharge, and 3, 6, 12, and 24 months ]
    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

  8. Evolution of daily proteinuria level [ Time Frame: hospital discharge, and 3, 6, 12, and 24 months ]
    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

  9. 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.

  10. Post-transplantation time to return to work [ Time Frame: 24 month ]
  11. Compliance of patients [ Time Frame: six months prior to surgery, hospital discharge, and 3, 6, 12, and 24 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients waiting a kidney transplantation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154815


Contacts
Contact: Emmanuelle PAPUCHON 02 40 08 77 82 ext +33 emmanuelle.papuchon@chu-nantes.fr

Locations
France
CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique Active, not recruiting
Lyon, France, 69437
CHU MARSEILLE - Hôpital de la Conception - Santé Publique Recruiting
Marseille, France, 13005
Contact: Stéphanie GENTILE       stephanie.gentile@ap-hm.fr   
Principal Investigator: Stéphanie GENTILE         
CHU MONTPELLIER - Hôpital Lapeyronie - Service de Néphrologie Terminated
Montpellier, France, 34000
CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN Recruiting
Nantes, France, 44093
Contact: Aurélie MEURETTE       aurelie.meurette@chu-nantes.fr   
Contact: Magalie GIRAL       magali.giral@chu-nantes.fr   
Principal Investigator: Aurélie MEURETTE         
Sub-Investigator: Magalie GIRAL         
CHU NICE - Service de Néphrologie Recruiting
Nice, France, 06002
Contact: Elisabeth CASSUTO       cassuto.e@chu-nice.fr   
Principal Investigator: Elisabeth CASSUTO         
AP-HP - Hôpital St Louis - Service de Néphrologie et Transplantation Rénale Active, not recruiting
Paris, France, 75475
AP-HP Hopital Necker Not yet recruiting
Paris, France
Principal Investigator: Rebecca SBERRO SOUSSAN, MD         
CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie Active, not recruiting
Toulouse, France, 61059
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Director: Véronique SEBILLE CHU Nantes
Principal Investigator: Aurélie MEURETTE CHU Nantes

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02154815     History of Changes
Other Study ID Numbers: RC14_0078
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Nantes University Hospital:
End Stage Renal Disease
Renal transplantation
Dialysis
Pre-emptive transplantation
Psychological adjustment
Quality of life.