Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil
Phase 4
Completed
- Conditions
- Maintenance Kidney Transplant
- Interventions
- Registration Number
- NCT00400647
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).
Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mycophenolate mofetil Mycophenolate mofetil 250 mg or 500 mg in two equal doses EC MPS Enteric-coated Mycophenolate sodium (EC-MPS) Up to 1440mg taken in two doses
- Primary Outcome Measures
Name Time Method To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms 12 weeks
- Secondary Outcome Measures
Name Time Method To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB) 12 weeks To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects 12 weeks
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland