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OpenTrials
Completed

NCT Number: NCT01615900

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)

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.

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Key information

Conditions

Renal Transplant Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleconsultation / Standard consultation

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: TELEGRAFT

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2012
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.