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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

Primary Purpose

Renal Anemia Associated With Chronic Renal Failure (CRF)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
roxadustat
darbepoetin alfa
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia Associated With Chronic Renal Failure (CRF) focused on measuring Chronic Renal Failure, ASP1517, Renal anemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

ASP1517 Low dose group

ASP1517 Middle dose group

ASP1517 High dose group

Darbepoetin group

Arm Description

Participants received an oral dose of ASP1517 three times a week.

Participants received an oral dose of ASP1517 three times a week.

Participants received an oral dose of ASP1517 three times a week.

Participants received Darbepoetin alfa intravenously once a week.

Outcomes

Primary Outcome Measures

Rate of rise in hemoglobin (g/dL/week)

Secondary Outcome Measures

Cumulative number of responder patients
Responder is defined as a hemoglobin >10.0 g/dL and an increase in hemoglobin by >1.0 g/dL from baseline
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
Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit

Full Information

First Posted
June 25, 2013
Last Updated
December 31, 2019
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01888445
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
September 15, 2014 (Actual)
Study Completion Date
September 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia Associated With Chronic Renal Failure (CRF)
Keywords
Chronic Renal Failure, ASP1517, Renal anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP1517 Low dose group
Arm Type
Experimental
Arm Description
Participants received an oral dose of ASP1517 three times a week.
Arm Title
ASP1517 Middle dose group
Arm Type
Experimental
Arm Description
Participants received an oral dose of ASP1517 three times a week.
Arm Title
ASP1517 High dose group
Arm Type
Experimental
Arm Description
Participants received an oral dose of ASP1517 three times a week.
Arm Title
Darbepoetin group
Arm Type
Active Comparator
Arm Description
Participants received Darbepoetin alfa intravenously once a week.
Intervention Type
Drug
Intervention Name(s)
roxadustat
Other Intervention Name(s)
ASP1517
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Intervention Description
iv
Primary Outcome Measure Information:
Title
Rate of rise in hemoglobin (g/dL/week)
Time Frame
Baseline and at Week-6
Secondary Outcome Measure Information:
Title
Cumulative number of responder patients
Description
Responder is defined as a hemoglobin >10.0 g/dL and an increase in hemoglobin by >1.0 g/dL from baseline
Time Frame
up to Week-24
Title
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
Title
Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit
Time Frame
for 28 weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokuriku
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyushu
Country
Japan
City
Shikoku
Country
Japan
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
36005278
Citation
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=355
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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