A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia

October 29, 2024 updated by: Astellas Pharma Inc

A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Japan
      • Aichi, Japan
        • Site JP00003
      • Aichi, Japan
        • Site JP00005
      • Aichi, Japan
        • Site JP00042
      • Aichi, Japan
        • Site JP00044
      • Chiba, Japan
        • Site JP00020
      • Ehime, Japan
        • Site JP00010
      • Ehime, Japan
        • Site JP00021
      • Fukuoka, Japan
        • Site JP00013
      • Fukushima, Japan
        • Site JP00011
      • Fukushima, Japan
        • Site JP00035
      • Gifu, Japan
        • Site JP00017
      • Gifu, Japan
        • Site JP00033
      • Gunma, Japan
        • Site JP00012
      • Gunma, Japan
        • Site JP00016
      • Gunma, Japan
        • Site JP00025
      • Hiroshima, Japan
        • Site JP00046
      • Hokkaido, Japan
        • Site JP00015
      • Hokkaido, Japan
        • Site JP00023
      • Hokkaido, Japan
        • Site JP00028
      • Hokkaido, Japan
        • Site JP00038
      • Hokkaido, Japan
        • Site JP00040
      • Hokkaido, Japan
        • Site JP00045
      • Hyogo, Japan
        • Site JP00034
      • Ibaraki, Japan
        • Site JP00008
      • Ibaraki, Japan
        • Site JP00018
      • Ibaraki, Japan
        • Site JP00027
      • Ibaraki, Japan
        • Site JP00030
      • Ishikawa, Japan
        • Site JP00022
      • Kagoshima, Japan
        • Site JP00041
      • Kumamoto, Japan
        • Site JP00031
      • Kumamoto, Japan
        • Site JP00037
      • Nagano, Japan
        • Site JP00009
      • Nagano, Japan
        • Site JP00014
      • Nagano, Japan
        • Site JP00026
      • Nagano, Japan
        • Site JP00047
      • Niigata, Japan
        • Site JP00002
      • Niigata, Japan
        • Site JP00029
      • Okayama, Japan
        • Site JP00039
      • Okinawa, Japan
        • Site JP00024
      • Osaka, Japan
        • Site JP00036
      • Saitama, Japan
        • Site JP00006
      • Shizuoka, Japan
        • Site JP00032
      • Tokushima, Japan
        • Site JP00043
      • Tokyo, Japan
        • Site JP00048
      • Tottori, Japan
        • Site JP00007
      • Toyama, Japan
        • Site JP00019
      • Yamaguchi, Japan
        • Site JP00004

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mean of the subjects' two most recent Hb values during the Screening Period must be ≤10.0 g/dL with an absolute difference ≤1.0 g/dL between the two values
  • Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
  • Female subject must either:

Be of non-childbearing potential:

  • post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
  • documented surgically sterile Or, if of childbearing potential,
  • Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
  • And have a negative pregnancy test at Screening

  • And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.

    • Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
    • Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
    • Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
    • Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration

Exclusion Criteria:

  • Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
  • Concurrent autoimmune disease with inflammation that could impact erythropoiesis
  • History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis
  • Uncontrolled hypertension
  • Concurrent congestive heart failure (NYHA Class III or higher)
  • History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
  • Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
  • Concurrent other form of anemia than renal anemia
  • Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
  • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment
  • Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
  • Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment
  • Having undergone a kidney transplantation
  • Having a previous history of treatment with ASP1517.
  • History of serious drug allergy including anaphylactic shock
  • Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP1517 Low dose Group
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
Drug: roxadustat
Oral
Other Names:
  • ASP1517
Experimental: ASP1517 High dose Group
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
Drug: roxadustat
Oral
Other Names:
  • ASP1517

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin (Hb) Response rate
Time Frame: Up to Week 24
Hb response is defined as reaching target values for Hb and change of Hb from baseline
Up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to achieve the lower limit of the target Hb level
Time Frame: Up to Week 24
Up to Week 24
Quality of life assessed by FACT-An
Time Frame: Up to Week 24
FACT-An: Functional Assessment of Cancer Therapy-Anemia
Up to Week 24
Safety assessed by incidence of adverse events
Time Frame: Up to Week 24
Up to Week 24
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time Frame: Up to Week 24
Up to Week 24
Safety assessed by standard 12-lead electrocardiogram
Time Frame: Up to Week 24
Up to Week 24
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time Frame: Up to Week 24
Up to Week 24
Plasma concentration of unchanged ASP1517
Time Frame: Up to Week 24
Up to Week 24
Average Hb level from Week 18 to 24
Time Frame: Week 18 to 24
Week 18 to 24
Change from baseline in the average Hb level from Week 18 to 24
Time Frame: Baseline and Weeks 18 to 24
Baseline and Weeks 18 to 24
Proportion of participants with the target Hb level from Week 18 to 24
Time Frame: Week 18 to 24
Week 18 to 24
Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment
Time Frame: Up to Week 4
Up to Week 4
Proportion of measurement points with the target Hb level
Time Frame: Up to Week 24
Up to Week 24
Proportion of participants with the target Hb level at each week
Time Frame: Up to Week 24
Up to Week 24
Proportion of participants with the lower limit of the target Hb level
Time Frame: Up to Week 24
Up to Week 24
Change from baseline in Hb levels to each week
Time Frame: Baseline and Up to Week 24
Baseline and Up to Week 24
Average hematocrit level
Time Frame: Up to Week 24
Up to Week 24
Average reticulocyte level
Time Frame: Up to Week 24
Up to Week 24
Average iron (Fe) level
Time Frame: Up to Week 24
Up to Week 24
Average ferritin level
Time Frame: Up to Week 24
Up to Week 24
Average transferrin level
Time Frame: Up to Week 24
Up to Week 24
Average total iron binding capacity level
Time Frame: Up to Week 24
Up to Week 24
Average soluble transferrin receptor level
Time Frame: Up to Week 24
Up to Week 24
Average transferrin saturation level
Time Frame: Up to Week 24
Up to Week 24
Average reticulocyte hemoglobin content level
Time Frame: Up to Week 24
Up to Week 24
Quality of life assessed by EQ-5D-5L
Time Frame: Up to Week 24
EQ-5D-5L: EuroQol 5 Dimension 5 Levels
Up to Week 24
Number of hospitalizations
Time Frame: Up to Week 24
Up to Week 24
Duration of hospitalizations
Time Frame: Up to Week 24
Up to Week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FibroGen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1517-CL-0308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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