Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carlucci G Ventura | UNKNOWN |
| Daniel R Salomon | UNKNOWN |
| Fabiana Agena | UNKNOWN |
| Flavio J de Paula |
Not provided
Not provided
Not provided
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard maintenance immunosuppression | Active Comparator | tacrolimus, mycophenolate and prednisone |
|
| fourth maintenance immunosuppressive | Experimental | everolimus, tacrolimus, mycophenolate and prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | mTORi added as the fourth maintenance immunosuppressive drug in recipients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of acute rejection and/or positive viremia for CMV | First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients. | From enrollment to the end of treatment at 52 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Transplantation Service | Recruiting | São Paulo | 05403-900 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
| Francine B Lemos | UNKNOWN |
| Gislene Bezerra | UNKNOWN |
| Helcio Rodrigues | UNKNOWN |
| Maria da Luz Fernandes | UNKNOWN |
| Nelson Zocoler Galante | UNKNOWN |
| Noemia B de Lima | UNKNOWN |
| Paschoalina Romano | UNKNOWN |
| Patricia S Souza | UNKNOWN |
| Vivian Onuchic | UNKNOWN |
| Elias David Neto | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| standard maintenance immunosuppression | Drug | standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone |
|
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided