Anemia, Hemodialysis, Renal Impairment
Conditions
Keywords
FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
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.
Interventions
DRUGroxadustat
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASP1517 concentrations in plasma | For 96 hours after dosing |
Secondary
| Measure | 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 | For 96 hours after dosing |
Countries
Japan
Outcome results
None listed