ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
NCT ID: NCT01083888
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2010-02-15
2010-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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1 group
Participants received a single oral dose of ASP1517 on Days 1 and 8
roxadustat
oral
Interventions
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roxadustat
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight: \>=40.0 and \<80.0 kg
* Mean hemoglobin level \>=10.0 and =\<12.0 g/dL
Exclusion Criteria
* Patients who have a medical history of gastrointestinal surgery or enterectomy
* Patients who have uncontrolled hypertension
* Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
* Patients who have a medical history of severe cardiac or cerebrovascular diseases
* Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks
* Patients with a medical history of serious drug allergies
* Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period
20 Years
74 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chūbu, , Japan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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1517-CL-0203
Identifier Type: -
Identifier Source: org_study_id
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