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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653041
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):
Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Everolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors
Study Start Date : August 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Everolimus
Single arm
Drug: Everolimus

Primary Outcome Measures :
  1. Efficacy compound outcome [ Time Frame: 12 months ]
    Incidence of treatment failure, defined as the first occurrence of biopsy confirmed acute rejection, graft loss, death, or treatment discontinuation.

Secondary Outcome Measures :
  1. acute rejection, allograft and patient survival. [ Time Frame: 12 months ]

    Acute rejection Type of acute rejection: clinical acute rejection; biopsy confirmed acute rejection; Timing of acute rejection; Severity of acute rejection, based on Banff 2007 classification; Treatment modality: steroids; polyclonal antibodies; change in immunosuppressive regimen Outcome: resolved; partially resolved; graft loss Allograft Renal function measured by creatinine and calculated creatinine clearance (MDRD formula); proteinuria including microalbuminuria and urinary protein- creatinine ratio; histology at month 12, including optic, fluorescence and electronic microscopy; graft loss, including incidence and cause.

    Patient Cardiovascular safety: blood pressure; glucose metabolism; lipids profile;Infections: site of infection, microorganism and treatment; everolimus related adverse reaction: event, time of transplant and outcome; malignancies: type, time of transplant and outcome; death, including incidence and causes.

Other Outcome Measures:
  1. Exploratory evaluations [ Time Frame: 12 months ]
    At some study visits will be obtained blood and urine samples for exploratory analyzes on immune tolerance, biomarkers such as CD30 and FOXP3 and genetic polymorphism of enzymes and transporters targets of immunosuppressants used. For crossmatch cell will be used cells derived from peripheral blood of the donor as a stimulus to cells in vitro receptor.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653041

Hospital do Rim e Hipertensão
São Paulo, Brazil, 04038-002
Sponsors and Collaborators
Hospital do Rim e Hipertensão

Responsible Party: Helio Tedesco Silva Junior, PhD, Hospital do Rim e Hipertensão Identifier: NCT01653041     History of Changes
Other Study ID Numbers: CRAD001ABR26T
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão:
immunosuppression, identical HLA, kidney transplantation, everolimus

Additional relevant MeSH terms:
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents