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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in the Grafalon group | 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 | Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grafalon | Other | None interventional study but there are two groups |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database | 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 | During one year |
| Measure | Description | Time Frame |
|---|---|---|
| Recipient Efficacy (any adverse events) | 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) | During one year |
| Recipient Safety (any adverse events) |
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Inclusion Criteria:
age (donor and recipient) gender indication (immunological indication versus DFG) CMV status
Exclusion Criteria:
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Patients who have received or are receiving induction ATGs at the time of transplantation and whose data are collected from the ASTRE base in the 13 renal transplant centrers participating in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yannick LE MEUR | Contact | 298-347-074 | yannick.lemeur@chu-brest.fr | |
| Christelle RATAJCZAK | Contact | 298-347-061 | christelle.ratajczak@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie, Hopital Sud | Not yet recruiting | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
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Comparison during the first year between the two groups for various infections (virus, bacteria, fungi), hematological adverse event (SAE or not) |
| During one year |
| Reconstitution of the T, and B cell populations | Reconstitution of the T, and B cell populations at D0, D7, M3, M12 | During one year |
| Cost comparison | Hospitals costs at 1 year months (including re-hospitalisation costs) | During one year |
| CHU d'Angers | Not yet recruiting | Angers | 49933 | France |
|
| CHRU de Brest | Recruiting | Brest | 29609 | France |
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| CHU Hopital Clemenceau | Not yet recruiting | Caen | 14033 | France |
|
| CHU Hopital Gabriel Montpied | Not yet recruiting | Clermont-Ferrand | 63003 | France |
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| CHU Dupuytren 2 | Recruiting | Limoges | 87000 | France |
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| Hopital Necker Enfant Malade | Not yet recruiting | Paris | 75743 | France |
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| CHU La Milétrie | Not yet recruiting | Poitiers | 86021 | France |
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| CHU Hopital Maison Blanche | Not yet recruiting | Reims | 51092 | France |
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| CHU de Rennes | Not yet recruiting | Rennes | 35033 | France |
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| CHU Hopital de Bois Guillaume | Not yet recruiting | Rouen | 76230 | France |
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| Hopitaux Universitaires de Strasbourg - Hopital civil | Not yet recruiting | Strasbourg | 67091 | France |
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| CHRU de Tours | Not yet recruiting | Tours | 37044 | France |
|