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

NCT01888445 | Completed Phase 2

• 1 other identifier: 1517-CL-0304
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Renal Anemia Associated With Chronic Renal Failure (CRF)

Keywords

Chronic Renal Failure; ASP1517; Renal anemia

Outcome Measures

Primary Outcomes (1)

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

  Baseline and at Week-6

Secondary Outcomes (3)

• Cumulative number of responder patients

  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

  for 28 weeks after dosing

• Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit

  for 28 weeks after dosing

Study Arms (4)

ASP1517 Low dose group

EXPERIMENTAL

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

Drug: roxadustat

ASP1517 Middle dose group

EXPERIMENTAL

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

Drug: roxadustat

ASP1517 High dose group

EXPERIMENTAL

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

Drug: roxadustat

Darbepoetin group

ACTIVE COMPARATOR

Participants received Darbepoetin alfa intravenously once a week.

Drug: darbepoetin alfa

Interventions

roxadustat DRUG

oral

Also known as: ASP1517

ASP1517 High dose group; ASP1517 Low dose group; ASP1517 Middle dose group

darbepoetin alfa DRUG

iv

Darbepoetin group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokuriku, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (1)

• 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.

  PMID: 36005278 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

roxadustat; Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: March 28, 2013
• Primary Completion: September 15, 2014
• Study Completion: September 15, 2014
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

JP (8)