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This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).
All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.
A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori.
Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels > 1.5 mg/dL or death by a cerebrovascular accident.
DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Active Comparator | SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone |
|
| mycophenolate sodium | No Intervention | SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Molecular profile of cytokines | To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection | To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival | 12 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Abbud, MD.PhD | Contact | 551740099191 | mabbud@terra.com.br | |
| Amanda Calori | Contact | 551740099167 | estudos@iun.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Mario Abbud, MD.PhD | Instituto de Urologia e Nefrologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Urologia e Nefrologia | Recruiting | São José do Rio Preto | São Paulo | 15015-200 | Brazil |
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Instituto de Urologia e Nefrologia | Recruiting | São José do Rio Preto | São Paulo | 15015-200 | Brazil |
|
| Instituto de Urologia e Nefrologia | Recruiting | São José do Rio Preto | São Paulo | 15015200 | Brazil |
|