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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)

NCT01615900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2020-01-13

No results posted yet for this study

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.

Conditions

  • Renal Transplant Patient

Interventions

OTHER

Teleconsultation / 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 & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-07
Primary Completion
2020-01-07
Completion
2020-01-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615900 on ClinicalTrials.gov