A Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis

Not Applicable

Terminated

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT02746146
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Study Start: 2017-04-05
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The % number of registrants on the kidney transplant waiting list	12 months

Secondary Outcome Measures

Name	Time	Method
Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list	12 months	This outcome integrates the the duration of initial assessment and is measured by the difference between the start and end dates of the pre-transplant assessment.
The number of refusals by patients for registration on the kidney transplant waiting list	12 months
In case of patient refusal for registration, the reasons why (qualitative approach)	12 months
The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list	12 months
In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach)	12 months
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	12 months

Trial Locations

Locations (25)

Clinique Claude Bernard; 🇫🇷 Albi, France

AIDER - Unité de Dialyse d'Alès; 🇫🇷 Alès, France

CH d'Auch; 🇫🇷 Auch, France

Centre d'Hemodialyse Languedoc Méditérranéen; 🇫🇷 Béziers, France

Medipole Grand Sud St Roch; 🇫🇷 Cabestany, France

CH de Cahors; 🇫🇷 Cahors, France

NephroCare; 🇫🇷 Castelnau le Lez, France

CH de Carcassonne; 🇫🇷 Cité De Carcassonne, France

AAIR Midi-Pyrénées; 🇫🇷 Colomiers, France

Centre Hospitalier Intercommunal du Val d'Ariège; 🇫🇷 Foix Cedex, France

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