NCT00154206CompletedPhase 4
A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
Novartis Pharmaceuticals1 site in 1 country15 target enrollmentStarted: September 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
Study Overview
Brief Summary
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recipients of a primary renal transplantation
- •Recipients of a renal transplantation only
Exclusion Criteria
- •Recipients of a multi-organ transplantation
- •Unable to take an oral medication
- •Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
- •Other protocol-defined inclusion / exclusion criteria may apply
Outcomes
Primary Outcomes
Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
Secondary Outcomes
- Within the 6 and 12 months post transplantation
- Incidence of acute rejection resistant to steroids
- Incidence of graft loss and death
- Renal function by creatinine and creatinine clearance (Schwartz formula)
- Incidence of premature study drug discontinuation due to safety reason
- Pharmacokinetic profile of Myfortic.
- Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
Investigators
Study Sites (1)
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