Comparison Thymoglobulin® and Grafalon®

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I

Conditions
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Renal Transplantation

Intervention / Treatment
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* Other: Grafalon


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients in the Grafalon group<br>Patients in the Grafalon group (n=150) will be followed prospectively and data prospectively collected thanks to the Astre database | Other: Grafalon<br>* None interventional study but there are two groups<br>* Other names: Thymoglobulin;|
| Patients in the Thymoglobulin group<br>Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database | Other: Grafalon<br>* None interventional study but there are two groups<br>* Other names: Thymoglobulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THYMOGLOBULINE®, GRAFALON®