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

NCT01895049 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2017-08-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Helio Tedesco Silva Junior

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-03-31
Completion
2017-03-07

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895049 on ClinicalTrials.gov