NCT00149968CompletedPhase 4
Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium
Study Overview
Brief Summary
The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Received kidney transplant at least 3 months prior to study enrollment
- •Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
- •Receiving MMF for at least 1 month prior to enrollment
Exclusion Criteria
- •Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
- •If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- •Acute rejection < 1 week prior to study enrollment
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Myfortic
Experimental
Intervention: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)
Outcomes
Primary Outcomes
Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium
Time Frame: week 0, week 6-8
Secondary Outcomes
- Gastrointestinal symptoms under MMF-based immunosuppressive therapy(week 0, week 6-8)
- Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life(week 0, week 6-8)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney TransplantsPancreas TransplantationKidney TransplantationNCT00267150Novartis Pharmaceuticals31
Completed
Phase 3
Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant RecipientsLiver TransplantationNCT00405652Novartis Pharmaceuticals34
Completed
Phase 3
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With MycophenolateAutoimmune DiseaseNCT00351377Novartis Pharmaceuticals111
Completed
Phase 4
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) TherapyKidney TransplantationLiver TransplantationNCT00149942Novartis23
Completed
Phase 4
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) IntoleranceRenal TransplantationNCT00400400Novartis Pharmaceuticals400