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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
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To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection within 24 weeks (6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1) | at 6 months | |
| Time to first acute rejection episode | for 6 months | |
| 6 month patient and graft survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Korea, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu | South Korea | |||||
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| MR4 | Drug | oral |
|
|
| at 6 months |
| Severity of acute rejection | 6 months |
| Adverse events, laboratory parameters and vital signs | Throughout trial |
| Seoul |
| South Korea |