ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
- Registration Number
- NCT01083888
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Chronic renal failure patients receiving hemodialysis thrice weekly
- Body weight: >=40.0 and <80.0 kg
- Mean hemoglobin level >=10.0 and =<12.0 g/dL
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Exclusion Criteria
- Patients with severe inflammation or infection
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 group roxadustat Participants received a single oral dose of ASP1517 on Days 1 and 8
- Primary Outcome Measures
Name Time Method ASP1517 concentrations in plasma For 96 hours after dosing
- Secondary Outcome Measures
Name Time Method 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 For 96 hours after dosing