NCT02746146

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

25 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

March 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

April 18, 2016

Last Update Submit

March 2, 2021

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • The % number of registrants on the kidney transplant waiting list

    12 months

Secondary Outcomes (6)

  • Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list

    12 months

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Chronic dialysis patients

EXPERIMENTAL

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

Other: Systematic use of a prognostic score

Interventions

Systematic use of a prognostic scoreOTHER

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

Chronic dialysis patients

Eligibility Criteria

Age70 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • The patient is participating in another interventional 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Clinique Claude Bernard

Albi, 81000, France

Location

AIDER - Unité de Dialyse d'Alès

Alès, 30100, France

Location

CH d'Auch

Auch, 32008, France

Location

Centre d'Hemodialyse Languedoc Méditérranéen

Béziers, 34500, France

Location

Medipole Grand Sud St Roch

Cabestany, 66330, France

Location

CH de Cahors

Cahors, France

Location

NephroCare

Castelnau-le-Lez, 34170, France

Location

CH de Carcassonne

Cité de Carcassonne, 11000, France

Location

AAIR Midi-Pyrénées

Colomiers, France

Location

Centre Hospitalier Intercommunal du Val d'Ariège

Foix, 09017, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

AIDER de Montpellier

Montpellier, 34295, France

Location

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Clinique de l'Occitanie

Muret, 31603, France

Location

Polyclinique Le Languedoc

Narbonne, 11000, France

Location

AIDER - Unité de Dialyse de Nîmes

Nîmes, 30029, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Gardialyse

Nîmes, 30900, France

Location

CH de Perpignan - Hôpital Saint Jean

Perpignan, 66046, France

Location

Centre Hospitalier Jacques Puel

Rodez, 12000, France

Location

CH de Bigorre

Tarbes, 65013, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

CHRU de Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

CHRU de Toulouse - Hôptal Casselardit

Toulouse, 31059, France

Location

Clinique Néphrologique Saint-Exupéry

Toulouse, 31077, France

Location

Related Publications (1)

  • 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.

    PMID: 25671769BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Moranne, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

April 5, 2017

Primary Completion

March 2, 2020

Study Completion

March 2, 2020

Last Updated

March 4, 2021

Record last verified: 2021-02

Locations

FR(25)