Comparison Thymoglobulin® and Grafalon®
- Conditions
- Renal Transplantation
- Interventions
- Other: Grafalon
- Registration Number
- NCT03996278
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
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.
- Detailed Description
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.
Justification for a non-interventional study: in the study the medicinal products will be prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to the product is not decided in advance by a trial protocol but falls within current practice of the centre and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients in the Grafalon group Grafalon Patients in the Grafalon group (n=150) will be followed prospectively and data prospectively collected thanks to the Astre database Patients in the Thymoglobulin group Grafalon Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database
- Primary Outcome Measures
Name Time Method Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database During one year All events: Death, graft loss, acute rejection, DGF, de novo DSA Severe infection (SAE), hematological adverse event (SAE), CMV infection, BK virus infection, MACE(major cardiac adverse event) and cancer
- Secondary Outcome Measures
Name Time Method Cost comparison During one year Hospitals costs at 1 year months (including re-hospitalisation costs)
Recipient Efficacy (any adverse events) During one year comparison during the first year between the two groups for: patient and graft survival, delayed graft function, one year rate of acute rejection, occurrence od de novo DSA, renal function at one year (eGFR,MDRD)
Recipient Safety (any adverse events) During one year Comparison during the first year between the two groups for various infections (virus, bacteria, fungi), hematological adverse event (SAE or not)
Reconstitution of the T, and B cell populations During one year Reconstitution of the T, and B cell populations at D0, D7, M3, M12
Trial Locations
- Locations (13)
CHU d'Angers
🇫🇷Angers, France
CHU de Rennes
🇫🇷Rennes, France
CHU Hopital de Bois Guillaume
🇫🇷Rouen, France
CHRU de Brest
🇫🇷Brest, France
CHU Hopital Clemenceau
🇫🇷Caen, France
CHU La Milétrie
🇫🇷Poitiers, France
CHU Hopital Maison Blanche
🇫🇷Reims, France
CHU Dupuytren 2
🇫🇷Limoges, France
CHU Amiens Picardie, Hopital Sud
🇫🇷Amiens, France
CHU Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hopitaux Universitaires de Strasbourg - Hopital civil
🇫🇷Strasbourg, France
CHRU de Tours
🇫🇷Tours, France
Hopital Necker Enfant Malade
🇫🇷Paris, France