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

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895049
• Other study ID #: CRAD001ABR32T
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2013
• Last updated: August 11, 2017
• Start date: August 2013
• Est. completion date: March 7, 2017

Study information

• Verified date: August 2017
• Source: Hospital do Rim e Hipertensão
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 7, 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cytomegalovirus
• Kidney Transplantation

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Hospital do Rim e Hipertensao	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Helio Tedesco Silva Junior	Novartis, Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV disease	Incidence of CMV disease or infection during the first year of transplantation.	1 year
Secondary	incidence of treatment failure	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.	1 year