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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) (TELEGRAFT)

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ClinicalTrials.gov Identifier: NCT01615900
Recruitment Status : Recruiting
First Posted : June 11, 2012
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Renal Transplant Patient Other: Teleconsultation / Standard consultation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : February 7, 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Teleconsultation 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)
Standard consultation 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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cost-effectiveness of the personalized follow-up [ Time Frame: 2 years ]
  2. Quality of life linked to the health of transplant patients [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615900


Contacts
Contact: Aurélie MEURETTE, Dr +33 2 40 08 74 35 aurelie.meurette@chu-nantes.fr

Locations
France
Lyon University Hospital Withdrawn
Lyon, France
Nantes University Hospital Recruiting
Nantes, France
Contact: Aurélie MEURETTE, Dr    +33 2 40 08 74 35    aurelie.meurette@chu-nantes.fr   
Principal Investigator: Aurélie MEURETTE, Dr         
Necker Hospital / AP-HP Withdrawn
Paris, France
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01615900     History of Changes
Other Study ID Numbers: BRD/11/06-O
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Nantes University Hospital:
Renal graft
Teleconsultation
Kidney transplant failure score