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The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine microemulsion | Experimental |
| |
| Tacrolimus | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine microemulsion | Drug |
| ||
| Tacrolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation. | ||
| Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus | ||
| percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation |
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Inclusion Criteria:
- First or second transplant, cadaveric or living donor
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26328072 | Result | Ekmekcioglu O, Turkan S, Yildiz S, Gunes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004. |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation |
| percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation |
| incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) | 6 months |
| Blood pressure at Months 3& 6 post-transplantation |
| incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation. |