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NCT Number: NCT02154815

Pre-emptive Kidney Transplantation Quality of Life

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.

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Key information

Conditions

Renal Insuffiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaires : Patient-Reported Outcomes

Other

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

Primary outcomes

  1. Change in quality of life

    Time frame: 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 outcomes

  1. Generic quality of life

    Time frame: 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.

  2. Anxiety and depressive disorders

    Time frame: 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)

  3. Subjective well-being

    Time frame: 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)

  4. Perceived stress

    Time frame: 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

  5. Coping strategies

    Time frame: 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

  6. Posttraumatic growth

    Time frame: 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)

  7. Evolution of the Graft Filtration Rate

    Time frame: 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

  8. Evolution of daily proteinuria level

    Time frame: 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

  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: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PreKiTQoL

Important dates

Study start
2014
Primary completion
2018
Study completion
2024
First posted
Jun 3, 2014
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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