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NCT Number: NCT01083888

ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

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.

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Key information

Conditions

Anemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemodialysis Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chūbu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roxadustat

Drug

oral

Other names: ASP1517

Primary outcomes

  1. ASP1517 concentrations in plasma

    Time frame: For 96 hours after dosing

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 10, 2010
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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