Phase 3
N=31
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Pancreas Transplantation · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00267150 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium — -0.46 Change in Score of GSRS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium |
-0.46 | — |
| SECONDARY Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy |
19; 12; 4; 3; 11; 1 | — |
Summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.
Eligibility Criteria
Inclusion Criteria
- Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to study enrollment
- Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least for three months at time of study enrollment)
- Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.
Exclusion Criteria
- Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also SCP of EC-MPS)
- If applicable, GI symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection < 1 month prior to study enrollment
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00267150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.