NCT01895049

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Helio Tedesco Silva Junior · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation
• Cytomegalovirus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-03-01
• Completion: 2017-03-07
• First posted: 2013-07-10
• Last updated: 2017-08-15

Locations

1 site across 1 country: Brazil