Clinical trial NCT02746146: A Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis
Official title: Impact of a Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 46
Sex: ALL
Minimum age (years): 70
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.

This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.

Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.

Detailed description: The secondary objectives are:

A. To show that the systematic use of the score at the initiation of dialysis can shorten the registration delay on a kidney transplant waiting list; to evaluate the time between initiation of dialysis and registration on a national waiting list for kidney transplants, while assessing the duration of the pre-transplant assessment.

B. To identify barriers to registration on the kidney transplant waiting list as well as the related time delay in this population (medical and non-medical factors), the rates and causes of patient refusal for registration and the possible evolution this refusal over time.

C. To evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* Patient initiating chronic dialysis (incident cases)
* Patients with a 3 year prognostic mortality score less than (\<) 10 points (Dusseux et al. 2015)

Exclusion Criteria:

* The patient is participating in another interventional study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient on preemptive kidney transplant waiting list (before the initiation of a chronic dialysis program)

Primary outcomes:
measure: The % number of registrants on the kidney transplant waiting list
timeFrame: 12 months
Secondary outcomes:
measure: Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list
timeFrame: 12 months
measure: The number of refusals by patients for registration on the kidney transplant waiting list
timeFrame: 12 months
measure: In case of patient refusal for registration, the reasons why (qualitative approach)
timeFrame: 12 months
measure: The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list
timeFrame: 12 months
measure: In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach)
timeFrame: 12 months
measure: The cost of care associated with dialysis patients and dialysed-and-then-transplanted patients will be estimated from the point of view of the French health insurance system
timeFrame: 12 months
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Alès
country: France
facility: AIDER - Unité de Dialyse d'Alès
city: Auch
country: France
facility: CH d'Auch
city: Béziers
country: France
facility: Centre d'Hemodialyse Languedoc Méditérranéen
city: Cabestany
country: France
facility: Medipole Grand Sud St Roch
city: Cahors
country: France
facility: CH de Cahors
city: Castelnau le Lez
country: France
facility: NephroCare
city: Cité De Carcassonne
country: France
facility: CH de Carcassonne
city: Colomiers
country: France
facility: AAIR Midi-Pyrénées
city: Foix Cedex
country: France
facility: Centre Hospitalier Intercommunal du Val d'Ariège
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Montpellier
country: France
facility: AIDER de Montpellier
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Muret Cedex
country: France
facility: Clinique de l'Occitanie
city: Narbonne
country: France
facility: Polyclinique Le Languedoc
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes Cedex 9
country: France
facility: AIDER - Unité de Dialyse de Nîmes
city: Nîmes
country: France
facility: Gardialyse
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint Jean
city: Rodez
country: France
facility: Centre Hospitalier Jacques Puel
city: Tarbes Cedex 9
country: France
facility: CH de Bigorre
city: Toulouse Cedex 4
country: France
facility: Clinique Néphrologique Saint-Exupéry
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Larrey
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôptal Casselardit
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Olivier Moranne, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dusseux E, Albano L, Fafin C, Hourmant M, Guerin O, Couchoud C, Moranne O. A simple clinical tool to inform the decision-making process to refer elderly incident dialysis patients for kidney transplant evaluation. Kidney Int. 2015 Jul;88(1):121-9. doi: 10.1038/ki.2015.25. Epub 2015 Feb 11.