ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

January 6, 2020 updated by: Astellas Pharma Inc

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 group
Participants received a single oral dose of ASP1517 on Days 1 and 8
Drug: roxadustat
oral
Other Names:
  • ASP1517

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASP1517 concentrations in plasma
Time Frame: For 96 hours after dosing
For 96 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
ASP1517 concentrations in dialysate
Time Frame: For 6 hours after dosing
For 6 hours after dosing
Plasma EPO level
Time Frame: Pre dosing and for 24 hours after dosing
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
For 96 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2010

Primary Completion (ACTUAL)

June 7, 2010

Study Completion (ACTUAL)

June 7, 2010

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1517-CL-0203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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