ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis

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.

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