Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
This trial is active, not recruiting.
|Conditions||kidney transplantation, cytomegalovirus|
|Treatments||induction therapy with thymoglobulin, prednisone, everolimus and late introduction of tacrolimus, induction therapy with thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus|
|Sponsor||Helio Tedesco Silva Junior|
|Start date||August 2013|
|End date||March 2016|
|Trial size||200 participants|
|Trial identifier||NCT01895049, CRAD001ABR32T|
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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Incidence of CMV disease
time frame: 1 year
incidence of treatment failure
time frame: 1 year
Male or female participants at least 18 years old.
- 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)
- 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).
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