Informations générales (source: ClinicalTrials.gov)
Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
Interventional
Phase 4
University Hospital, Tours (Voir sur ClinicalTrials)
juillet 2013
mars 2015
02 mai 2026
The purpose of this study is to compare parallel-group effects between 4 months and 12
months post-transplantation 2 values of target residual concentrations of Advagraf on
vascular parameters in de novo renal transplant patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | Christophe LEGENDRE | Contact (sur clinicalTrials) | |||
| GPE HOSP BROUSSAIS HEGP | Eric THERVET | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Tours - Tours - France | Yvon LEBRANCHU | Contact (sur clinicalTrials) | |||
| CHU de Amiens - Amiens - France | Pierre-François WESTEEL | Contact (sur clinicalTrials) | |||
| CHU de Angers - Angers - France | Jean-François SUBRA | Contact (sur clinicalTrials) | |||
| CHU de Caen - Caen - France | Bruno HURAULT DE LIGNY | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Anne-Elisabeth HENG | Contact (sur clinicalTrials) | |||
| CHU de Rennes - Rennes - France | Cécile VIGNEAU | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Isabelle ETIENNE | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - Strasbourg - France | Bruno MOULIN | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Toulouse - France | Lionel ROSTAING | Contact (sur clinicalTrials) | |||
Critères
Tous
- Age between 18 et 70 years
- Patient accepting to give a written informed consent
- Recipients of a first renal allograft (deceased or living, non HLA identical donor
with compatible ABO blood type)
- Randomized in the ADEQUATE study
- Patients must have at J112 +/- 3 days a stable renal function (MDRD 4) with an
absence of DSA since transplantation.
- Negative T cross-match in cytotoxicity
- Tolerate a daily dose of MMF at 1g
Exclusion Criteria:
- Acute rejection during the first months
- Existence of a BK infection since M3
- Proteinuria/reatininuria ratio > 1g/g since M3