Clinical trial NCT01653041: Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors
Official title: Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: immunosuppression, identical HLA, kidney transplantation, everolimus
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2012-07-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy compound outcome
timeFrame: 12 months
Secondary outcomes:
measure: acute rejection, allograft and patient survival.
timeFrame: 12 months
Other outcomes:
measure: Exploratory evaluations
timeFrame: 12 months
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim e Hipertensão
Study officials:
References: