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

NCT01895049 | Completed Phase 4

• 1 other identifier: CRAD001ABR32T
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Cytomegalovirus

Keywords

Tacrolimus; Everolimus; Cytomegalovirus; Thymoglobulin; Deceased donors; Expanded criteria

Outcome Measures

Primary Outcomes (1)

• Incidence of CMV disease

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

  1 year

Secondary Outcomes (1)

• incidence of treatment failure

  1 year

Study Arms (2)

Mycophenolate sodium

ACTIVE COMPARATOR

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

Everolimus

EXPERIMENTAL

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

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

Interventions

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

Everolimus

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

Mycophenolate sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Helio Tedesco Silva Junior: lead
• Novartis: collaborator
• Sanofi: collaborator

Study Sites (1)

Hospital do Rim e Hipertensao

São Paulo, 04038-002, Brazil

Location

Related Publications (2)

• Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.

  PMID: 40197799 DERIVED

• Ferreira AN, Felipe CR, Cristelli M, Viana L, Mansur J, de Paula M, Wagner D, de Marco R, Gerbase-DeLima M, Proenca H, Aguiar W, Medina-Pestana J, Tedesco-Silva Junior H. Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor. Transpl Int. 2019 Nov;32(11):1127-1143. doi: 10.1111/tri.13478. Epub 2019 Aug 27.

  PMID: 31278785 DERIVED

MeSH Terms

Interventions

Neoadjuvant Therapy; thymoglobulin; Prednisone; Everolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sirolimus; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 7, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

BR (1)