ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

• Status: Completed
• Trial end date: 2010-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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