Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
Information source: Hospital do Rim e Hipertensão
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation; Cytomegalovirus
Intervention: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus (Drug); Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Helio Tedesco Silva Junior Overall contact: Helio Tedesco, PhD, Phone: 55-11-5087-8113, Email: heliotedesco@hrim.com.br
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of CMV disease
Secondary outcome: incidence of treatment failure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Helio Tedesco, PhD, Phone: 55-11-5087-8113, Email: heliotedesco@hrim.com.br
Hospital do Rim e Hipertensao, São Paulo 04038-002, Brazil; Recruiting Claudia R Felipe, PhD, Phone: 55 11 5087-8113, Email: claudiafelipe@medfarm.com.br Nagilla I Oliveira, Master, Phone: 55-11-5087-8113, Email: nagilla.oliveira@medfarm.com.br Helio Tedesco, PhD, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: March 20, 2015
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