Overview

This trial is active, not recruiting.

Conditions kidney transplantation, cytomegalovirus
Treatments induction therapy with thymoglobulin, prednisone, everolimus and late introduction of tacrolimus, induction therapy with thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus
Phase phase 4
Sponsor Helio Tedesco Silva Junior
Collaborator Novartis
Start date August 2013
End date March 2016
Trial size 200 participants
Trial identifier NCT01895049, CRAD001ABR32T

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus
induction therapy with thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus
(Experimental)
Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus.
induction therapy with thymoglobulin, prednisone, everolimus and late introduction of tacrolimus

Primary Outcomes

Measure
Incidence of CMV disease
time frame: 1 year

Secondary Outcomes

Measure
incidence of treatment failure
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital do Rim e Hipertensão.