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Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors


Phase 4
18 Years
N/A
Not Enrolling
Both
Kidney Transplantation

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Trial Information

Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors


Inclusion Criteria:



1. Adult candidates of first or repeat kidney transplant HLA identical living donors;

2. Patient who signed the informed consent form to participate in this study;

Exclusion Criteria:

1. Patients were excluded if they had been receiving immunosuppressive therapy before
transplantation;

2. Patients who received an investigational medication within the past 12 months;

3. Patients with suspected or known to have an infection or were seropositive for
hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen
(anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);

4. Patient who had had cancer (except nonmelanoma skin cancer) within the previous 2
years.

5. Pregnant women, nursing mothers, and women of childbearing potential who were not
using condoms or oral contraceptives were excluded.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy compound outcome

Outcome Description:

Incidence of treatment failure, defined as the first occurrence of biopsy confirmed acute rejection, graft loss, death, or treatment discontinuation.

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

Study ID:

CRAD001ABR26T

NCT ID:

NCT01653041

Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Kidney Transplantation
  • immunosuppression, identical HLA, kidney transplantation, everolimus

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