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

This study is not yet open for participant recruitment.
Verified July 2012 by Hospital do Rim e Hipertensão
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier:
NCT01653041
First received: July 26, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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 Intervention Phase
Kidney Transplantation
 Drug: Everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital do Rim e Hipertensão:

Primary Outcome Measures:
  • Efficacy compound outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of treatment failure, defined as the first occurrence of biopsy confirmed acute rejection, graft loss, death, or treatment discontinuation.


Secondary Outcome Measures:
  • acute rejection, allograft and patient survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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:
  • Exploratory evaluations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Single arm
 Drug: Everolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653041

Contacts
Contact: Hélio Tedesco-Silva, PhD 55-11-5087-8179 heliotedesco@hrim.com.br
Contact: Cláudia Rosso Felipe, PhD 55-11-5087-8113 claudiafelipe@medfarm.com.br

Locations
Brazil
Hospital do Rim e Hipertensão Not yet recruiting
São Paulo, Brazil, 04038-002
Contact: Cláudia Rosso Felipe, PhD     55-11-50878113     claudiafelipe@medfarm.com.br    
Contact: Nagilla Ione Oliveira, Master     55-11-5087-8113     nagilla.oliveira@medfarm.com.br    
Sponsors and Collaborators
Hospital do Rim e Hipertensão
Novartis
  More Information

No publications provided

Responsible Party: Helio Tedesco Silva Junior, PhD, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier: NCT01653041     History of Changes
Other Study ID Numbers: CRAD001ABR26T
Study First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

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

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013