NCT01964196已完成2 期
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-
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Rate of rise in Hb (g/dL/week) at Week 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ASP1517 low dose group
Experimental
Oral
干预措施: ASP1517 (Drug)
ASP1517 middle dose group
Experimental
Oral
干预措施: ASP1517 (Drug)
ASP1517 high dose group
Experimental
Oral
干预措施: ASP1517 (Drug)
Placebo group
Placebo Comparator
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of rise in Hb (g/dL/week) at Week 6
时间窗: Baseline and at 6 weeks after dosing
次要结局
- 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)
- 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)
研究者
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