Renal Transplant PatientTELEGRAFTNCT01615900
Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)
A study testing Teleconsultation / Standard consultation in people with Renal Transplant Patient, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Patient
- What is being tested?
- Teleconsultation / Standard consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2012to 7 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Having received a deceased donor renal transplant one year ago
- Having an access internet high-speed
- Having a compatible computer and supporting the videoconference
- Calculable KTFS (Kidney Transplant Failure Score)
- Patient having participated in a therapeutic educational program
- Patient has given informed consent
- Patient insured
Who cannot join
- Patient under age 18
- Patient having received a multi-organ transplant (heart kidney / liver kidney / kidney pancreas / lung kidney / heart lung kidney)
- Patient non-compliant
- BK virus nephropathy or BK positive viremia
- CMV positive viremia
- Identified and treated psychiatric disorders
- Participation in another clinical study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.
- Conditions
- Renal Transplant Patient
- Being tested
- Teleconsultation / Standard consultation
- Keywords
- Renal graft, Teleconsultation, Kidney transplant failure score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleconsultation / Standard consultationOther
Stage 1: randomization. Two arms: teleconsultation and standard consultation
Stage 2: calculation of Kidney Transplant Failure Score which will determine 4 sub-groups: teleconsultation high risk, teleconsultation low risk, standard consultation high risk and standard consultation low risk.
Stage 3: follow-up (2 years) according to the group:
- Standard consultation low risk: consultation every 2 months during one year and then every 3 months during one year
- Standard consultation high risk: consultation every 6 weeks during one year and then every 2 months during one year
- Teleconsultation low risk: same follow-up as "standard consultation low risk" group but all the consultations are teleconsultations
- Teleconsultation high risk: same follow-up as "standard consultation high risk" group but the follow-up will be intensified by the addition of an intermediate teleconsultation (between 2 consultations)
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation | Other | Not described Receives: Other: Teleconsultation / Standard consultation |
| Standard consultation | Other | Not described Receives: Other: Teleconsultation / Standard consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events
The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.
Measured: 2 years
Secondary outcomes (2)
Cost-effectiveness of the personalized follow-up
Measured: 2 years
Quality of life linked to the health of transplant patients
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 posted11 Jun 2012 (estimated)
- Study start7 Feb 2012
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
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 Renal Transplant PatientStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615900
- Sponsor's protocol ID
- BRD/11/06-O
- Acronym
- TELEGRAFT
- Status last verified
- Jan 2020
- First submitted
- 7 Jun 2012
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foucher Y, Meurette A, Daguin P, Bonnaud-Antignac A, Hardouin JB, Chailan S, Neau K, Papuchon E, Gaboriau S, Legendre C, Morelon E, Tessier P, Giral M. A personalized follow-up of kidney transplant recipients using video conferencing based on a 1-year scoring system predictive of long term graft failure (TELEGRAFT study): protocol for a randomized controlled trial. BMC Nephrol. 2015 Jan 28;16:6. doi: 10.1186/1471-2369-16-6.
PubMed 25631635
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)
- ClinicalTrials.gov ID
- NCT01615900
- Acronym / sponsor ID
- TELEGRAFT / BRD/11/06-O
- Conditions
- Renal Transplant Patient
- Keywords
- Renal graft, Teleconsultation, Kidney transplant failure score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2012 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 11 Jun 2012 (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 optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | Other | Other: Teleconsultation / Standard consultation |
| Standard consultation | Other | Other: Teleconsultation / Standard consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient
- Having received a deceased donor renal transplant one year ago
- Having an access internet high-speed
- Having a compatible computer and supporting the videoconference
- Calculable KTFS (Kidney Transplant Failure Score)
Key exclusion criteria (8 listed)
- Patient under age 18
- Patient having received a multi-organ transplant (heart kidney / liver kidney / kidney pancreas / lung kidney / heart lung kidney)
- Patient non-compliant
- BK virus nephropathy or BK positive viremia
- CMV positive viremia
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 |
|---|---|---|
| Teleconsultation / Standard consultationStage 1: randomization. Two arms: teleconsultation and standard consultation Stage 2: calculation of Kidney Transplant Failure Score which will determine 4 sub-groups: teleconsultation high risk, teleconsultation low risk, standard consultation high risk and standard consultation low risk. Stage 3: follow-up (2 years) according to the group: * Standard consultation low risk: consultation every 2 months during one year and then every 3 months during one year * Standard consultation high risk: consultation every 6 weeks during one year and then every 2 months during one year * Teleconsultation low risk: same follow-up as "standard consultation low risk" group but all the consultations are teleconsultations * Teleconsultation high risk: same follow-up as "standard consultation high risk" group but the follow-up will be intensified by the addition of an intermediate teleconsultation (between 2 consultations) | Other | Standard consultation, Teleconsultation |
Primary outcome
Number of serious adverse events
Time frame: 2 years
The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.
2 secondary outcomes
Cost-effectiveness of the personalized follow-up
Time frame: 2 years
Quality of life linked to the health of transplant patients
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 25631635Foucher Y, Meurette A, Daguin P, Bonnaud-Antignac A, Hardouin JB, Chailan S, Neau K, Papuchon E, Gaboriau S, Legendre C, Morelon E, Tessier P, Giral M. A personalized follow-up of kidney transplant recipients using video conferencing based on a 1-year scoring system predictive of long term graft failure (TELEGRAFT study): protocol for a randomized controlled trial. BMC Nephrol. 2015 Jan 28;16:6. doi: 10.1186/1471-2369-16-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation / Standard consultation in people with Renal Transplant Patient, run by Nantes University Hospital at 1 site 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of serious adverse events (time frame: 2 years). 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 NCT01615900, 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 14 Sep 2026.