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The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-coated mycophenolate sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance | within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events | within 3 months | |
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18091520 | Derived | Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. doi: 10.1097/01.tp.0000290678.06523.95. |
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| within 1 month |
| Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection | within 3 months |
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups | after 3 months |