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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adults (> 18 years) candidates to renal transplant with expanded criteria deceased


- 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


- 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

Page last updated: August 23, 2015

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