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ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01083888
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Anemia Hemodialysis Renal Impairment Drug: roxadustat Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
Actual Study Start Date : February 15, 2010
Actual Primary Completion Date : June 7, 2010
Actual Study Completion Date : June 7, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arm Intervention/treatment
Experimental: 1 group
Participants received a single oral dose of ASP1517 on Days 1 and 8
Drug: roxadustat
oral
Other Name: ASP1517




Primary Outcome Measures :
  1. ASP1517 concentrations in plasma [ Time Frame: For 96 hours after dosing ]

Secondary Outcome Measures :
  1. ASP1517 concentrations in dialysate [ Time Frame: For 6 hours after dosing ]
  2. Plasma EPO level [ Time Frame: Pre dosing and for 24 hours after dosing ]
  3. Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests [ Time Frame: For 96 hours after dosing ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083888


Locations
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Japan
Chubu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01083888    
Other Study ID Numbers: 1517-CL-0203
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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."
Keywords provided by Astellas Pharma Inc:
FG-4592
ASP1517
Safety and tolerability
Plasma concentration
Pharmacokinetics
Additional relevant MeSH terms:
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Renal Insufficiency
Anemia
Hematologic Diseases
Kidney Diseases
Urologic Diseases