Status:
COMPLETED
Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
Lead Sponsor:
Helio Tedesco Silva Junior
Collaborating Sponsors:
Novartis
Sanofi
Conditions:
Kidney Transplantation
Cytomegalovirus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2017
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01895049
Start Date
August 1 2013
End Date
March 7 2017
Last Update
August 15 2017
Active Locations (1)
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1
Hospital do Rim e Hipertensao
São Paulo, Brazil, 04038-002