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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019859-21 | EudraCT Number |
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Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advagraf | Experimental |
| |
| Prograf | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| determine steady state systemic exposure (AUC 0-24h) | Day 1, Day 3, Day 7 and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| determine Cmax (maximum concentration) | Day 1, Day 3, Day 7 and Day 42 | |
| determine tmax (time to attain Cmax) | Day 1, Day 3, Day 7 and Day 42 | |
| determine C24 (concentration prior to next morning dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | Austria | |||||
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| Label | URL |
|---|---|
| Link to results on EudraCT | View source |
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| Prograf | Drug | oral |
|
|
| Day 1, Day 3, Day 7 and Day 42 |
| describe rejection episodes | up to 58 weeks |
| describe subject survival | up to 58 weeks |
| describe graft survival | up to 58 weeks |
| Leuven |
| Belgium |
| Paris | France |
| Milan | Italy |
| Padova | Italy |
| Taipei | Taiwan |
| London | United Kingdom |
| Manchester | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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