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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

Conditions
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Anemia in Chronic Kidney Disease Patients Not on Dialysis

Intervention / Treatment
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* Drug: ASP1517
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1517 low dose group<br>Oral | Drug: ASP1517<br>* Oral administration<br>|
| Experimental: ASP1517 middle dose group<br>Oral | Drug: ASP1517<br>* Oral administration<br>|
| Experimental: ASP1517 high dose group<br>Oral | Drug: ASP1517<br>* Oral administration<br>|
| Placebo Comparator: Placebo group<br>Oral | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rise in Hb (g/dL/week) at Week 6 |  | Baseline and at 6 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of cumulative number of responder patients | responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL | for 28 weeks after dosing | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal anemia, Chronic Renal Failure, ASP1517