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

This study is currently recruiting participants.
Verified June 2013 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: June 28, 2013
Last verified: June 2013

July 26, 2012
June 28, 2013
August 2012
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01653041 on ClinicalTrials.gov Archive Site
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.

Same as current
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.
Same as current
 
Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors
Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Drug: Everolimus
Experimental: Everolimus
Single arm
Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2014
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Brazil
 
NCT01653041
CRAD001ABR26T
No
Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
Hospital do Rim e Hipertensão
Novartis
Not Provided
Hospital do Rim e Hipertensão
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP