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

NCT ID: NCT02746146

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2020-03-02

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Chronic dialysis patients

The study population consists of patients over 70 (≥) and under 85 years (<) of age with stage 5 chronic renal disease and initiating a first session of chronic dialysis in the Languedoc-Roussillon and Midi-Pyrénées regions. Eligible patients must have a 3 year prognostic mortality score less than (<) 7 points (Dusseux et al. 2015).

Intervention: Systematic use of a prognostic score

Group Type: EXPERIMENTAL

Systematic use of a prognostic score

Intervention Type: OTHER

The prognostic score is given in Dusseux et al 2015. It will be used as soon as possible after the initiation of dialysis.

Interventions

Systematic use of a prognostic score

The prognostic score is given in Dusseux et al 2015. It will be used as soon as possible after the initiation of dialysis.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Moranne, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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, , France

Clinique du Pont de Chaume

Montauban, , France

AIDER de Montpellier

Montpellier, , France

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Clinique de l'Occitanie

Muret, , France

Polyclinique Le Languedoc

Narbonne, , France

AIDER - Unité de Dialyse de Nîmes

Nîmes, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Gardialyse

Nîmes, , France

CH de Perpignan - Hôpital Saint Jean

Perpignan, , France

Centre Hospitalier Jacques Puel

Rodez, , France

CH de Bigorre

Tarbes, , France

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, , France

CHRU de Toulouse - Hôpital Larrey

Toulouse, , France

CHRU de Toulouse - Hôptal Casselardit

Toulouse, , France

Clinique Néphrologique Saint-Exupéry

Toulouse, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 25671769 (View on PubMed)

Other Identifiers

2016-A00464-47

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2015/OM-01

Identifier Type: -

Identifier Source: org_study_id