ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

NCT01083888 | Completed Phase 1

• 1 other identifier: 1517-CL-0203
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Hemodialysis; Renal Impairment

Keywords

FG-4592; ASP1517; Safety and tolerability; Plasma concentration; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• ASP1517 concentrations in plasma

  For 96 hours after dosing

Secondary Outcomes (3)

• 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

Study Arms (1)

1 group

EXPERIMENTAL

Participants received a single oral dose of ASP1517 on Days 1 and 8

Drug: roxadustat

Interventions

roxadustat DRUG

oral

Also known as: ASP1517

1 group

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Chūbu, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Anemia; Renal Insufficiency

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: February 15, 2010
• Primary Completion: June 7, 2010
• Study Completion: June 7, 2010
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)