Kidney Failure, ChronicKITENCT02746146
A Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis
A study testing Systematic use of a prognostic score in people with Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Nīmes at 25 sites in France.
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… Read more about this study
- Who is it for?
- Ages 70 to 84 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Systematic use of a prognostic score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 25 sitesFrance
- Study dates
- 5 Apr 2017to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Clinique Claude Bernard
Albi, 81000
AIDER - Unité de Dialyse d'Alès
Alès, 30100
CH d'Auch
Auch, 32008
Centre d'Hemodialyse Languedoc Méditérranéen
Béziers, 34500
Medipole Grand Sud St Roch
Cabestany, 66330
CH de Cahors
Cahors
NephroCare
Castelnau-le-Lez, 34170
CH de Carcassonne
Cité de Carcassonne, 11000
AAIR Midi-Pyrénées
Colomiers
Centre Hospitalier Intercommunal du Val d'Ariège
Foix, 09017
Clinique du Pont de Chaume
Montauban, 82017
AIDER de Montpellier
Montpellier, 34295
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Clinique de l'Occitanie
Muret, 31603
Polyclinique Le Languedoc
Narbonne, 11000
AIDER - Unité de Dialyse de Nîmes
Nîmes, 30029
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Gardialyse
Nîmes, 30900
CH de Perpignan - Hôpital Saint Jean
Perpignan, 66046
Centre Hospitalier Jacques Puel
Rodez, 12000
CH de Bigorre
Tarbes, 65013
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
CHRU de Toulouse - Hôpital Larrey
Toulouse, 31059
CHRU de Toulouse - Hôptal Casselardit
Toulouse, 31059
Clinique Néphrologique Saint-Exupéry
Toulouse, 31077
About this study
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
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.
Read the detailed description
The secondary objectives are:
- 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.
- 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.
- To evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Systematic use of a prognostic score
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Systematic use of a prognostic score |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % number of registrants on the kidney transplant waiting list
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
The number of refusals by patients for registration on the kidney transplant waiting list
Measured: 12 months
In case of patient refusal for registration, the reasons why (qualitative approach)
Measured: 12 months
The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list
Measured: 12 months
In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach)
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start5 Apr 2017
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746146
- Sponsor's protocol ID
- PHRC-I/2015/OM-01
- Other IDs
- 2016-A00464-47
- Acronym
- KITE
- Status last verified
- Feb 2021
- First submitted
- 18 Apr 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25671769
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02746146
- Acronym / sponsor ID
- KITE / PHRC-I/2015/OM-01
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic dialysis patients | Experimental | Other: Systematic use of a prognostic scoreThe 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 |
Who may qualify
- Ages
- 70 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic 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. | Other | Chronic dialysis patients |
Primary outcome
The % number of registrants on the kidney transplant waiting list
Time frame: 12 months
6 secondary outcomes
Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list
Time frame: 12 months
The number of refusals by patients for registration on the kidney transplant waiting list
Time frame: 12 months
In case of patient refusal for registration, the reasons why (qualitative approach)
Time frame: 12 months
The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list
Time frame: 12 months
In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach)
Time frame: 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
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Background: PubMed 25671769Dusseux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Moranne, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic use of a prognostic score in people with Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Nīmes at 25 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % number of registrants on the kidney transplant waiting list (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.