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The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Intravenous Prograf therapy followed by oral Advagraf therapy |
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| Arm 2 | Active Comparator | Intravenous Prograf therapy followed by oral Prograf therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration | Day 6 and day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration) of tacrolimus plasma concentration | Day 6 and day 21 | |
| Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30098071 | Derived | Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Prograf | Drug | oral |
|
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| Prograf | Drug | intravenous |
|
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| Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) | up to 24 weeks |
| Safety assessed by the incidence of adverse events and lab-tests | up to 24 weeks |
| Link to results on Astellas Clinical Study Results website | View source |