ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01083888
First received: March 8, 2010
Last updated: June 16, 2010
Last verified: June 2010
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ASP1517 concentrations in dialysate [ Time Frame: For 6 hours after dosing ] [ Designated as safety issue: No ]
  • Plasma EPO level [ Time Frame: Pre dosing and for 24 hours after dosing ] [ Designated as safety issue: No ]
  • Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests [ Time Frame: For 96 hours after dosing ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083888

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01083888     History of Changes
Other Study ID Numbers: 1517-CL-0203
Study First Received: March 8, 2010
Last Updated: June 16, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 21, 2014