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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteric-coated mycophenolate sodium | Drug | oral |
| |
| everolimus | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range | 7 days | |
| Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the treatment regimen consisting over a one year period | 1 year | |
| Renal function during the course of the trial, especially after CNI withdrawal. | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Klemens Budde, Prof. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Universitätsmedizin | Berlin | 10117 | Germany |
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| Routine laboratory parameters during the course of the trial. |
| 1 year |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
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