Clinical trial NCT02154815: Pre-emptive Kidney Transplantation Quality of Life
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insuffiency
Kidney Transplantation
Keywords: End Stage Renal Disease
Renal transplantation
Dialysis
Pre-emptive transplantation
Psychological adjustment
Quality of life.
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients waiting a kidney transplantation

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.

Eligibility 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.

Primary outcomes:
measure: Change in quality of life
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Generic quality of life
timeFrame: through study completion, an average of 5 years
measure: Anxiety and depressive disorders
timeFrame: through study completion, an average of 5 years
measure: Subjective well-being
timeFrame: through study completion, an average of 5 years
measure: Perceived stress
timeFrame: through study completion, an average of 5 years
measure: Coping strategies
timeFrame: through study completion, an average of 5 years
measure: Posttraumatic growth
timeFrame: through study completion, an average of 5 years
measure: Evolution of the Graft Filtration Rate
timeFrame: through study completion, an average of 5 years
measure: Evolution of daily proteinuria level
timeFrame: through study completion, an average of 5 years
measure: KTFS (Kidney Transplant Failure Score )
timeFrame: 12 month
measure: Post-transplantation time to return to work
timeFrame: 24 month
measure: Compliance of patients
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique
city: Marseille
country: France
facility: CHU MARSEILLE - Hôpital de la Conception - Santé Publique
city: Nantes
country: France
facility: CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN
city: Nice
country: France
facility: CHU NICE - Service de Néphrologie
city: Toulouse
country: France
facility: CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie
Study officials:
affiliation: Nantes University Hospital
name: Véronique SEBILLE
role: STUDY_DIRECTOR
affiliation: Nantes University Hospital
name: Aurélie MEURETTE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.