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OpenTrials
Completed

NCT Number: NCT01895049

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

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.

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Key information

Conditions

Kidney Transplantation Cytomegalovirus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital do Rim e Hipertensao

São Paulo, 04038-002, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

  1. Incidence of CMV disease

    Time frame: 1 year

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

Secondary outcomes

  1. incidence of treatment failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helio Tedesco Silva Junior

Other

Collaborators

  • Novartis
  • Sanofi

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 10, 2013
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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