ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.

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

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

Inclusion Criteria:

• Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion

• The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is <10.0 g/dL, with a difference of ≤1.0 g/dL between the two values

• Both TSAT>=5% and ferritin >=30 ng/mL at screening test

• Serum folate ≥4.0 ng/mL and Vitamin B12 ≥180 pg/mL at screening test

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 evidence of active gastroparesis.

• Uncontrollable hypertension (more than one third blood pressure values of diastolic BP >100 mmHg within 16 weeks prior to screening test including)

• Congestive heart failure (NYHA classification III or higher)

• Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test

• Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV)

• Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)

• Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test