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

• Status: Completed
• Trial end date: 2014-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darbepoetin alfa

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