Renal TransplantationAPT'xNCT03750331
Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.
A study testing Ap'Telecare and traditional schedule in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Ap'Telecare and traditional schedule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 738 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients transplanted for at least 3 months
- Stable renal graft function
Who cannot join
- No home internet access
- Major disability
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clermont-Ferrand, CHU Site Gabriel-Montpied
Clermont-Ferrand
CHU Saint-Etienne
Saint-Etienne
About this study
Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.
- Conditions
- Renal Transplantation
- Being tested
- Ap'Telecare, traditional schedule
- Keywords
- telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ap'TelecareOther
an internet application on a computer, tablet or smartphone
traditional scheduleOther
a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule
| Study group | Role | What they receive |
|---|---|---|
| traditional patient follow-up | Active comparator | a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) Receives: Other: traditional schedule |
| medically-tailored follow-up with Ap'Telecare | Experimental | a group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter). Receives: Other: Ap'Telecare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients experiencing at least one episode of graft dysfunction
graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)
Measured: 2 years
Secondary outcomes (9)
Failure of immunosuppressive treatment
Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic
Measured: 2 years
number of patients who needed to return to dialysis
Measured: 2 years
number of patients with acute or chronic transplant rejection
Measured: 2 years
Post-transplant complication
Measured: 2 years
Death
Measured: 2 years
Quality of life assessed
EuroQol group - 5 Dimensions ( EQ-5D) scale
Measured: 2 years
Level of anxiety and depression
Hospital Anxiety and Depression (HAD) scale
Measured: 2 years
Incremental cost-effectiveness evaluation criteria
Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).
Measured: 2 years
Evaluation criteria for the Budget Impact Analysis
Average cost saved per 100 patients treated in the "Ap'Telecare group" compared to the "traditional follow-up".
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start17 Dec 2018
- Primary completion10 Oct 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
- Masking
- None (open label)
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Christophe Mariat, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750331
- Sponsor's protocol ID
- 1708232
- Other IDs
- 2018-A00677-48
- Acronym
- APT'x
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2018
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.
- ClinicalTrials.gov ID
- NCT03750331
- Acronym / sponsor ID
- APT'x / 1708232
- Conditions
- Renal Transplantation
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 738 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Nov 2018 (actual)
- 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.
Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
| Arm | Type | Receives |
|---|---|---|
| traditional patient follow-up | Active comparator | Other: traditional schedulea group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) |
| medically-tailored follow-up with Ap'Telecare | Experimental | Other: Ap'Telecarea group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients transplanted for at least 3 months
- Stable renal graft function
Key exclusion criteria (2 listed)
- No home internet access
- Major disability
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 |
|---|---|---|
| Ap'Telecarean internet application on a computer, tablet or smartphone | Other | medically-tailored follow-up with Ap'Telecare |
| traditional schedulea group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule | Other | traditional patient follow-up |
Primary outcome
Patients experiencing at least one episode of graft dysfunction
Time frame: 2 years
graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)
9 secondary outcomes
Failure of immunosuppressive treatment
Time frame: 2 years
number of patients who needed to return to dialysis
Time frame: 2 years
number of patients with acute or chronic transplant rejection
Time frame: 2 years
Post-transplant complication
Time frame: 2 years
Death
Time frame: 2 years
Quality of life assessed
Time frame: 2 years
Level of anxiety and depression
Time frame: 2 years
Incremental cost-effectiveness evaluation criteria
Time frame: 2 years
Evaluation criteria for the Budget Impact Analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Christophe Mariat, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ap'Telecare and traditional schedule in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Saint Etienne at 2 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Patients experiencing at least one episode of graft dysfunction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.