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ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: March 8, 2010
Last updated: June 16, 2010
Last verified: June 2010
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 Intervention Phase
Renal Impairment Hemodialysis Anemia Drug: ASP1517 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

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

Enrollment: 12
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 group Drug: ASP1517
Other Name: FG-4592


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01083888

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

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01083888     History of Changes
Other Study ID Numbers: 1517-CL-0203
Study First Received: March 8, 2010
Last Updated: June 16, 2010

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

Additional relevant MeSH terms:
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017