Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Incidence of CMV disease
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Mycophenolate sodium
Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus
Intervention: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus (Drug)
Everolimus
Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus.
Intervention: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus (Drug)
Outcomes
Primary Outcomes
Incidence of CMV disease
Time Frame: 1 year
Incidence of CMV disease or infection during the first year of transplantation.
Secondary Outcomes
- incidence of treatment failure(1 year)
Investigators
Helio Tedesco Silva Junior
PhD
Hospital do Rim e Hipertensão