Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria

Study Overview
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Brief Summary
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The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.

Conditions
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Kidney Transplantation, Cytomegalovirus

Intervention / Treatment
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* Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus
* Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (> 18 years) candidates to renal transplant with expanded criteria deceased donors; Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) <50%. Signature of the informed consent form (ICF) Exclusion Criteria: Patients receiving immunosuppressive therapy before transplantation; Patients who have received an investigational drug within last 30 days; Patients with a known contraindication to the administration of an anti-thymocyte globulin; Patients with a positive test for human immunodeficiency virus (HIV); Patients who had cancer (except non-melanoma skin cancer) within last two years; Pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded; Patients with any Panel Reactive Antibody (PRA) equal to or higher than 50%, class I or class II, will also be excluded; Patients with positive test for parasites (protozoa and helminths).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycophenolate sodium<br>Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus | Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus<br> <br> |
| Experimental: Everolimus<br>Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus. | Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CMV disease | Incidence of CMV disease or infection during the first year of transplantation. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of treatment failure | To compare the two immunosuppressive regimens for the incidence of treatment failure defined as the composite endpoint of BPAR (biopsy-proven acute rejection), graft loss, death and loss to follow-up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Everolimus, Cytomegalovirus, Thymoglobulin, Deceased donors, Expanded criteria