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Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3mg/kg Group | Experimental | Patients will received Thymoglobuline 3mg/Kg (reduced dose) |
|
| 6mg/kg Group | Active Comparator | Patients will received Thymoglobuline 6mg/Kg (standard dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug | reduced dose (3mg/Kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection | Biopsy proven and all treated acute rejection episodes | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | All infections requiring hospitalization | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transplant ward of the Hospital do Fortaleza | Fortaleza | Ceará | 60175-205 | Brazil |
patient data are confidential e will not be share with other researchers.
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
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