Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria

H

Helio Tedesco Silva Junior

Status and phase

Completed
Phase 4

Conditions

Kidney Transplantation
Cytomegalovirus

Treatments

Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus
Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01895049
CRAD001ABR32T

Details and patient eligibility

About

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.

Enrollment

171 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

171 participants in 2 patient groups

Mycophenolate sodium
Active Comparator group
Description:
Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus
Treatment:
Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus
Everolimus
Experimental group
Description:
Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus.
Treatment:
Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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