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The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus/MPS/Prednisone | Active Comparator | This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm |
|
| Sirolimus/Low Tacrolimus/MPS/Prednisone | Experimental | Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid. |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of graft loss and/or death with graft function | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection | Up to one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nelson Z Galante, PhD | Contact | 55-11-2661-8089 | nelson.galante@hc.fm.usp.br | |
| Fabiana Agena, MS | Contact | 55-11-2661-8089 | fabiana.agena@hc.fm.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
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|
| No intervention | Drug |
|
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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