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Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EC MPS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month evaluation | ||
| patient and graft survival | ||
| acute rejection (suspected or biopsy confirmed) | ||
| graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate), | ||
| infections, adverse events, serious adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation |
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Inclusion criteria:
Exclusion criteria:
Other inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18021971 | Result | Wyzgal J, Niemczyk M, Ziolkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071. |
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