Renal Transplantation
Conditions
Keywords
THYMOGLOBULINE®, GRAFALON®
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.
Interventions
OTHERGrafalon
None interventional study but there are two groups
Sponsors
University Hospital, Brest
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Patient younger than 18 years old * Living donor * Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cost comparison | During one year | Hospitals costs at 1 year months (including re-hospitalisation costs) |
Countries
France
Contacts
Primary ContactYannick LE MEUR
Backup ContactChristelle RATAJCZAK
Outcome results
None listed