NCT00149916CompletedPhase 3
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Patients.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 139
- Primary Endpoint
- To assess gastro-intestinal tolerability
Study Overview
Brief Summary
Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107
Exclusion Criteria
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Mycophenolate sodium (enteric coated)
Experimental
Intervention: Mycophenolate sodium (enteric coated) (Drug)
Outcomes
Primary Outcomes
To assess gastro-intestinal tolerability
Secondary Outcomes
- Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.
Investigators
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