Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
Phase 4
Completed
- Conditions
- Kidney TransplantationLiver Transplantation
- Registration Number
- NCT00149942
- Lead Sponsor
- Novartis
- Brief Summary
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
Exclusion Criteria
- Recent graft rejection before the study
- Other pre-existing conditions that may cause gastro-intestinal complaints
- Use of other drugs known to cause gastro-intestinal complaints
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Gastro-intestinal adverse events before switch versus 3 months after switch
- Secondary Outcome Measures
Name Time Method Frequency of adverse events Frequency of infections Time to the first biopsy-proven rejection after conversion. Severity of biopsy-proven rejections after conversion. Proportion of patients who had graft loss after conversion.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland