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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)

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01615900
Acronym
TELEGRAFT
Enrollment
155
Registered
2012-06-11
Start date
2012-02-07
Completion date
2020-01-07
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant Patient

Keywords

Renal graft, Teleconsultation, Kidney transplant failure score

Brief 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.

Interventions

OTHERTeleconsultation / Standard consultation

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)

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of serious adverse events2 yearsThe 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.

Secondary

MeasureTime frame
Cost-effectiveness of the personalized follow-up2 years
Quality of life linked to the health of transplant patients2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026