Back to resultsASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
Primary Purpose
Anemia, Hemodialysis, Renal Impairment
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
roxadustat
Sponsored by
About this trial
This is an interventional basic science trial for Anemia focused on measuring FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 group
Arm Description
Participants received a single oral dose of ASP1517 on Days 1 and 8
Outcomes
Primary Outcome Measures
ASP1517 concentrations in plasma
Secondary Outcome Measures
ASP1517 concentrations in dialysate
Plasma EPO level
Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01083888
Brief Title
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
Official Title
ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2010 (Actual)
Primary Completion Date
June 7, 2010 (Actual)
Study Completion Date
June 7, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Hemodialysis, Renal Impairment
Keywords
FG-4592, ASP1517, Safety and tolerability, Plasma concentration, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 group
Arm Type
Experimental
Arm Description
Participants received a single oral dose of ASP1517 on Days 1 and 8
Intervention Type
Drug
Intervention Name(s)
roxadustat
Other Intervention Name(s)
ASP1517
Intervention Description
oral
Primary Outcome Measure Information:
Title
ASP1517 concentrations in plasma
Time Frame
For 96 hours after dosing
Secondary Outcome Measure Information:
Title
ASP1517 concentrations in dialysate
Time Frame
For 6 hours after dosing
Title
Plasma EPO level
Time Frame
Pre dosing and for 24 hours after dosing
Title
Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests
Time Frame
For 96 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=353
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
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