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ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

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Astellas

Status and phase

Completed
Phase 1

Conditions

Anemia
Renal Impairment
Hemodialysis

Treatments

Drug: roxadustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083888
1517-CL-0203

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

1 group
Experimental group
Description:
Participants received a single oral dose of ASP1517 on Days 1 and 8
Treatment:
Drug: roxadustat

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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