ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083888
• Other study ID #: 1517-CL-0203
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2010
• Est. completion date: June 7, 2010

Study information

• Verified date: January 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 7, 2010
• Est. primary completion date: June 7, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Hemodialysis
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• roxadustat
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASP1517 concentrations in plasma		For 96 hours after dosing
Secondary	ASP1517 concentrations in dialysate		For 6 hours after dosing
Secondary	Plasma EPO level		Pre dosing and for 24 hours after dosing
Secondary	Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests		For 96 hours after dosing

External Links

•   Link to results on Astellas Clinical Study Results website