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Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients

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: NCT00228020
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : August 25, 2010
Information provided by:

Brief Summary:
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.

Condition or disease Intervention/treatment Phase
Pediatric Kidney Transplantation Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) Drug: MMF, cyclosporine, steroids Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients
Study Start Date : May 2001
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Basiliximab
Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
Active Comparator: Basiliximab-free
Patients will be on a regimen of MMF, cyclosporine and steroids.
Drug: MMF, cyclosporine, steroids

Primary Outcome Measures :
  1. Time to first BPAR episode or treatment failure [ Time Frame: 6 months ]
    Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients who are recipients of primary or secondary renal allograft.
  • Patients who are single-organ recipients (kidney only).

Exclusion Criteria:

•Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.

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): NCT00228020

Sponsors and Collaborators
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Study Director: Novartis Novartis

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Identifier: NCT00228020    
Other Study ID Numbers: CCHI621ADE01
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010
Keywords provided by Novartis:
pediatric, kidney transplantation, basiliximab
Additional relevant MeSH terms:
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Mycophenolic Acid
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents