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The study hypotheses to be tested in this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | Active Comparator | The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Tacrolimus |
|
| Everolimus | Active Comparator | The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Everolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate cumulative patient and graft survival at 12 months post conversion | Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of estimated glomerular filtration rate 12 months post-conversion | - To assess the efficacy of conversion from tacrolimus to everolimus 12 months post-conversion by measuring the estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) equation | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz Felipe S. Gonçalves, MD | Contact | lfgoncalves@hcpa.ufrgs.br | ||
| Nisséia Jahn, RN | Contact | nisseia@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Felipe S. Gonçalves, MD | HCPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D020123 | Sirolimus |
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| Everolimus |
| Drug |
Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred |
|