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

To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.

Age

20–74

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be 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 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

What this study is about