A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

December 31, 2019 updated by: Astellas Pharma Inc

A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia

This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.

Study Overview

Detailed Description

To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia.

To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in dialysis chronic kidney disease patients with anemia.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

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

      • Chubu, Japan
      • Chugoku, Japan
      • Hokuriku, Japan
      • Kansai, Japan
      • Kanto, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Tohoku, Japan

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who diagnosed as a end-stage kidney disease (ESKD) and are receiving stable chronic maintenance dialysis 3 times per week for ≥ 12 weeks
  • Patients who are receiving ESA for at least 8 weeks and the dose of ESA is within the dose range of ESA label
  • Hb value at screening test is ≥10.0 g/dL
  • Receiving hemodialysis via arteriovenous fistula (AVF) or arteriovenous graft (AVG) or via permanent catheter
  • Most recent two Hb values before dialysis during washout period must be both <9.5 g/dL and one of two Hb values must be tested on first visit of the week

Exclusion Criteria:

  • Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment
  • Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc)
  • Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or active gastroparesis
  • Uncontrollable hypertension (SBP ≥160 mmHg and DBP ≥110 mmHg, before dialysis, at screening test)
  • Congestive heart failure (NYHA classification III or higher)
  • Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration
  • Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
  • Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)
  • Pure red cell aplasia
  • Using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASP1517 Low dose group
Participants received an oral dose of ASP1517 three times a week.
oral
Other Names:
  • ASP1517
Experimental: ASP1517 Middle dose group
Participants received an oral dose of ASP1517 three times a week.
oral
Other Names:
  • ASP1517
Experimental: ASP1517 High dose group
Participants received an oral dose of ASP1517 three times a week.
oral
Other Names:
  • ASP1517
Active Comparator: Darbepoetin group
Participants received Darbepoetin alfa intravenously once a week.
iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of rise in hemoglobin (g/dL/week)
Time Frame: Baseline and at Week-6
Baseline and at Week-6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative number of responder patients
Time Frame: up to Week-24
Responder is defined as a hemoglobin >10.0 g/dL and an increase in hemoglobin by >1.0 g/dL from baseline
up to Week-24
Percent of visits at which patients maintain hemoglobin between 10.0-12.0 g/dL after achieving hemoglobin ≥10.0 g/dL for each patients
Time Frame: for 28 weeks after dosing
for 28 weeks after dosing
Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit
Time Frame: for 28 weeks after dosing
for 28 weeks after dosing

Collaborators and Investigators

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

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.

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)

March 28, 2013

Primary Completion (Actual)

September 15, 2014

Study Completion (Actual)

September 15, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

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
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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