Clinical Trials Directory

Trials / Terminated

TerminatedNCT02746146

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
70 Years – 84 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERSystematic use of a prognostic scoreThe prognostic score is given in Dusseux et al 2015. It will be used as soon as possible after the initiation of dialysis.

Timeline

Start date
2017-04-05
Primary completion
2020-03-02
Completion
2020-03-02
First posted
2016-04-21
Last updated
2021-03-04

Locations

25 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02746146. Inclusion in this directory is not an endorsement.