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

Status and phase: Completed; Phase 2

Conditions: Renal Anemia Associated With Chronic Renal Failure (CRF)

Treatments: Drug: darbepoetin alfa; Drug: roxadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01888445

1517-CL-0304

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

130 participants in 4 patient groups

ASP1517 Low dose group

Experimental group

Description:

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

Treatment:

Drug: roxadustat

ASP1517 Middle dose group

Experimental group

Description:

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

Treatment:

Drug: roxadustat

ASP1517 High dose group

Experimental group

Description:

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

Treatment:

Drug: roxadustat

Darbepoetin group

Active Comparator group

Description:

Participants received Darbepoetin alfa intravenously once a week.

Treatment:

Drug: darbepoetin alfa