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

Sponsor

Helio Tedesco Silva Junior (Other)

Overall Status

Completed

CT.gov ID

NCT01895049

Collaborator

Novartis (Industry), Sanofi (Industry)

171

Enrollment

Location

Arms

43.2

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Cytomegalovirus	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	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 7, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Mycophenolate sodium

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

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

Experimental: Everolimus

Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus.

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

Outcome Measures

Primary Outcome Measures

Incidence of CMV disease [1 year]
Incidence of CMV disease or infection during the first year of transplantation.

Secondary Outcome Measures

incidence of treatment failure [1 year]
To compare the two immunosuppressive regimens for the incidence of treatment failure defined as the composite endpoint of BPAR (biopsy-proven acute rejection), graft loss, death and loss to follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).