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

Kidney Failure, Chronic Clinical Trial

— KITE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02746146
• Other study ID #: PHRC-I/2015/OM-01
• Secondary ID: 2016-A00464-47
• Status: Terminated
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 84 Years

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	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	Clinique du Pont de Chaume	Montauban
France	AIDER de Montpellier	Montpellier
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	Clinique de l'Occitanie	Muret Cedex
France	Polyclinique Le Languedoc	Narbonne
France	Gardialyse	Nîmes
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	AIDER - Unité de Dialyse de Nîmes	Nîmes Cedex 9
France	CH de Perpignan - Hôpital Saint Jean	Perpignan
France	Centre Hospitalier Jacques Puel	Rodez
France	CH de Bigorre	Tarbes Cedex 9
France	Clinique Néphrologique Saint-Exupéry	Toulouse Cedex 4
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse Cedex 9
France	CHRU de Toulouse - Hôpital Larrey	Toulouse Cedex 9
France	CHRU de Toulouse - Hôptal Casselardit	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (1)

Dusseux E, Albano L, Fafin C, Hourmant M, Guérin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The % number of registrants on the kidney transplant waiting list		12 months
Secondary	Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list	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.	12 months
Secondary	The number of refusals by patients for registration on the kidney transplant waiting list		12 months
Secondary	In case of patient refusal for registration, the reasons why (qualitative approach)		12 months
Secondary	The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list		12 months
Secondary	In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach)		12 months
Secondary	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