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The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADVAGRAF group | Experimental |
| |
| PROGRAF group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVAGRAF | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) | Calculated by Modification of Diet in Renal Disease equation | at 24 weeks |
| Incidence of rejection reactions | at 24 weeks |
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Inclusion Criteria:
Only patients who meet the following inclusion criteria should be enrolled.
Exclusion Criteria:
Patients who fall under any of the following criteria should not be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
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| PROGRAF | Drug | oral |
|
|
| Blood pressure | at 24 weeks |
| Survival rate of the grafts | at 24 weeks |
| Subject's physical condition (SF-35) | Evaluation of subject's physical condition | at 24 weeks |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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