ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

Astellas

Status and phase

Completed

Phase 1

Conditions

Anemia

Renal Impairment

Hemodialysis

Treatments

Drug: roxadustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083888

1517-CL-0203

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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