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

NCT ID: NCT01653041

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-04-30

Brief Summary

Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population.

Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area.

The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus

Single arm

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Interventions

Everolimus

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Hospital do Rim e Hipertensão

OTHER

Sponsor Role: lead

Responsible Party

Helio Tedesco Silva Junior

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital do Rim e Hipertensão

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CRAD001ABR26T

Identifier Type: -

Identifier Source: org_study_id