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This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reduced Tacrolimus | Experimental |
| |
| Reference Tacrolimus | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EC-MPS, Tacrolimus | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| renal function at 6 months posttransplant as measured by glomerular filtration rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months | ||
| Renal function as measured by calculated creatinine clearance | ||
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Inclusion Criteria:
Exclusion Criteria
Other protocol-defined 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 | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23227307 | Result | Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25. |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Cockcroft-Gaultand serum creatinine at 6 months |
| Gastrointestinal tolerability as measured by gastrointestinal |
| symptom rating scale (GSRS) at various time points |
| Safety as measured by incidence of adverse events |
| Effects on glucose metabolism at months 3 and 6 after transplantation. |