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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01354301 |
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Date of registration:
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13/05/2011 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
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Scientific title:
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Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01354301 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Claudia R Felipe, PharmD |
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Address:
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Telephone:
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55-11-5087-8113 |
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Email:
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claudiafelipe@medfarm.com.br |
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Affiliation:
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Name:
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Cláudia R Felipe, PharmD |
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Address:
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Telephone:
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55-11-50878113 |
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Email:
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claudiafelipe@medfarm.com.br |
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Affiliation:
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Name:
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Hélio Tedesco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- low risk adult candidates for first renal transplants from living or deceased donors
Exclusion Criteria:
- receiving immunosuppressive therapy before transplantation;
- have received an investigational medication within the past 30 days;
- have a known contraindication to the administration of antithymocyte globulin;
- tested positive for human immunodeficiency virus (HIV);
- had had cancer (except nonmelanoma skin cancer) within the previous 2 years;
- Pregnant women, nursing mothers, and women of childbearing potential who will be not
using condoms or oral contraceptives will be excluded;
- Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or
class II.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cytomegalovirus Infection
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Renal Transplant Failure
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Transplant; Complication, Rejection
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Intervention(s)
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Drug: Basiliximabe
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Drug: Everolimus
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Drug: mycophenolate sodium
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Drug: Tacrolimus
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Drug: Thymoglobulin
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Primary Outcome(s)
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incidence of CMV infection or disease
[Time Frame: 1 year]
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Secondary Outcome(s)
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incidence of treatment failure defined as a composite end-point of BCAR, graft loss, death, loss to follow up.
[Time Frame: 1 year]
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Secondary ID(s)
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CRAD001ABR18T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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