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ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083888
First Posted: March 10, 2010
Last Update Posted: June 22, 2010
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.
Information provided by:
Astellas Pharma Inc
  Purpose
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
oral
Other Name: FG-4592

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
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
  Contacts and Locations
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
Japan
Chubu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01083888     History of Changes
Other Study ID Numbers: 1517-CL-0203
First Submitted: March 8, 2010
First Posted: March 10, 2010
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Safety and tolerability
Plasma concentration
ASP1517
FG-4592

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