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. Identifier: NCT01083888
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : June 22, 2010
Information provided by:
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
Renal Impairment Hemodialysis Anemia Drug: ASP1517 Phase 1

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 Pharmacology Study - PK/PD Study in Renal Anemia Patients on Hemodialysis
Study Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 group Drug: ASP1517
Other Name: FG-4592

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01083888

Chubu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01083888     History of Changes
Other Study ID Numbers: 1517-CL-0203
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
Safety and tolerability
Plasma concentration

Additional relevant MeSH terms:
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases