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

Astellas Pharma Inc130 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Renal Anemia Associated With Chronic Renal Failure (CRF)

Interventions

roxadustatDRUG

oral

darbepoetin alfaDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Chugoku, Japan

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokuriku, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kanto, Japan

Outcomes

Primary Outcomes

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

Time frame: Baseline and at Week-6

Secondary Outcomes

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

Time frame: 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

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

Time frame: for 28 weeks after dosing

Data from ClinicalTrials.gov

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