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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myfortic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug | Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium | week 0, week 6-8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 |
|---|---|---|---|---|---|---|
| Bonn | Germany | |||||
| Novartis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18091520 | Background | 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. | |
| 21693250 |
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|
| Basel |
| Switzerland |
| Reinke P, Budde K, Hugo C, Petersen P, Schnuelle P, Fricke L, Scholz D, Sperschneider H, Bahner U, Kramer S, Fischer W, Arns W. Reduction of gastrointestinal complications in renal graft recipients after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplant Proc. 2011 Jun;43(5):1641-6. doi: 10.1016/j.transproceed.2011.01.184. |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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