Informations générales (source: ClinicalTrials.gov)
Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I (THYGRET)
Observational
University Hospital, Brest (Voir sur ClinicalTrials)
mai 2019
novembre 2021
29 juin 2024
This is a prospective, multicenter, observational, non -interventional study with
comparison with an historical cohort Investigators will compare the efficacy and safety
of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in
renal transplantation by evaluating patient survival, graft survival, delayed graft
function, acute rejection, DSA occurrence and toxicities, various infections including
CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.
Investigators will also compare cumulative treatment and follow up costs and other key
criteria available in the ASTRE database.
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 | Dany Anglicheau | 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 - 37044 - Tours - France | Matthias Buchler | Contact (sur clinicalTrials) | |||
| CHU d'Angers - 49933 - Angers - France | Agnès Duveau | Contact (sur clinicalTrials) | |||
| CHU de Rennes - 35033 - Rennes - France | Léonard Golbin | Contact (sur clinicalTrials) | |||
| CHU Dupuytren 2 - 87000 - Limoges - France | Jean-Philippe Rerolle | Contact (sur clinicalTrials) | |||
| CHU Hopital Clemenceau - 14033 - Caen - France | Nicolas Bouvier | Contact (sur clinicalTrials) | |||
| CHU Hopital de Bois Guillaume - 76230 - Rouen - France | Isabelle Etienne | Contact (sur clinicalTrials) | |||
| CHU Hopital Gabriel Montpied - 63003 - Clermont-Ferrand - France | Anne-Elisabeth Heng | Contact (sur clinicalTrials) | |||
| CHU Hopital Maison Blanche - 51092 - Reims - France | Charlotte Colosio | Contact (sur clinicalTrials) | |||
| CHU La Milétrie - 86021 - Poitiers - France | Antoine Thierry | Contact (sur clinicalTrials) | |||
| Hopitaux Universitaires de Strasbourg - Hopital civil - 67091 - Strasbourg - France | Sophie Caillard | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Brest - 29609 - Brest - France | Yannick Le Meur | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie, Hopital Sud - 80054 - Amiens - France | Pierre-François Westeel | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- For the Grafalon prospective group: all first 11-12 patients from the 13 transplant
centres receiving Grafalon according to the local practice
- For the Thymoglobulin group: a group of 130 patients matched for:
age (donor and recipient) gender indication (immunological indication versus DFG) CMV
status
- For the Grafalon prospective group: all first 11-12 patients from the 13 transplant
centres receiving Grafalon according to the local practice
- For the Thymoglobulin group: a group of 130 patients matched for:
age (donor and recipient) gender indication (immunological indication versus DFG) CMV
status
- Patient younger than 18 years old
- Living donor
- Donor after cardiac death (because the Maastricht 3 donors are authorized recently
in France)