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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

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ClinicalTrials.gov Identifier: NCT01888445
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Renal Anemia Associated With Chronic Renal Failure (CRF) Drug: roxadustat Drug: darbepoetin alfa Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2013
Actual Primary Completion Date : September 15, 2014
Actual Study Completion Date : September 15, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1517 Low dose group
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
oral
Other Name: ASP1517

Experimental: ASP1517 Middle dose group
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
oral
Other Name: ASP1517

Experimental: ASP1517 High dose group
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
oral
Other Name: ASP1517

Active Comparator: Darbepoetin group
Participants received Darbepoetin alfa intravenously once a week.
Drug: darbepoetin alfa
iv




Primary Outcome Measures :
  1. Rate of rise in hemoglobin (g/dL/week) [ Time Frame: Baseline and at Week-6 ]

Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit [ Time Frame: for 28 weeks after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888445


Locations
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Japan
Chubu, Japan
Chugoku, Japan
Hokuriku, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Shikoku, Japan
Tohoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01888445    
Other Study ID Numbers: 1517-CL-0304
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc:
Chronic Renal Failure
ASP1517
Renal anemia
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Darbepoetin alfa
Hematinics