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To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 group | Experimental | Participants received a single oral dose of ASP1517 on Days 1 and 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roxadustat | Drug | oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| ASP1517 concentrations in plasma | For 96 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| ASP1517 concentrations in dialysate | For 6 hours after dosing | |
| Plasma EPO level | Pre dosing and for 24 hours after dosing | |
| Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests |
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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 |
|---|---|---|---|---|---|---|
| Chūbu | Japan |
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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| For 96 hours after dosing |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |