ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
Phase 2
Completed
- Conditions
- Anemia in Chronic Kidney Disease Patients Not on Dialysis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01964196
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP1517 low dose group ASP1517 Oral ASP1517 middle dose group ASP1517 Oral ASP1517 high dose group ASP1517 Oral Placebo group Placebo Oral
- Primary Outcome Measures
Name Time Method Rate of rise in Hb (g/dL/week) at Week 6 Baseline and at 6 weeks after dosing
- Secondary Outcome Measures
Name Time Method Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb ≥10.0 g/dL for each patients for 28 weeks after dosing Change from baseline in Hb Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28 Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests for 28 weeks after dosing Percentage of cumulative number of responder patients for 28 weeks after dosing responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL
Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28