NCT01888445已完成2 期
A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia
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
- 130
- 主要终点
- Rate of rise in hemoglobin (g/dL/week)
研究概览
简要总结
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
详细描述
To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia.
To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in dialysis chronic kidney disease patients with anemia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who diagnosed as a end-stage kidney disease (ESKD) and are receiving stable chronic maintenance dialysis 3 times per week for ≥ 12 weeks
- •Patients who are receiving ESA for at least 8 weeks and the dose of ESA is within the dose range of ESA label
- •Hb value at screening test is ≥10.0 g/dL
- •Receiving hemodialysis via arteriovenous fistula (AVF) or arteriovenous graft (AVG) or via permanent catheter
- •Most recent two Hb values before dialysis during washout period must be both <9.5 g/dL and one of two Hb values must be tested on first visit of the week
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 active gastroparesis
- •Uncontrollable hypertension (SBP ≥160 mmHg and DBP ≥110 mmHg, before dialysis, at screening test)
- •Congestive heart failure (NYHA classification III or higher)
- •Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration
- •Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
- •Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)
- •Pure red cell aplasia
- •Using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration
研究组 & 干预措施
ASP1517 High dose group
Experimental
Participants received an oral dose of ASP1517 three times a week.
干预措施: roxadustat (Drug)
Darbepoetin group
Active Comparator
Participants received Darbepoetin alfa intravenously once a week.
干预措施: darbepoetin alfa (Drug)
ASP1517 Middle dose group
Experimental
Participants received an oral dose of ASP1517 three times a week.
干预措施: roxadustat (Drug)
ASP1517 Low dose group
Experimental
Participants received an oral dose of ASP1517 three times a week.
干预措施: roxadustat (Drug)
结局指标
主要结局
Rate of rise in hemoglobin (g/dL/week)
时间窗: Baseline and at Week-6
次要结局
- Percent of visits at which patients maintain hemoglobin between 10.0-12.0 g/dL after achieving hemoglobin ≥10.0 g/dL for each patients(for 28 weeks after dosing)
- Cumulative number of responder patients(up to Week-24)
- Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit(for 28 weeks after dosing)
研究者
相似试验
已完成
3 期
A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) TreatmentHemodialysis Patients With Renal AnemiaNCT02779764Astellas Pharma Inc164
已完成
3 期
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With AnemiaPeritoneal Dialysis Chronic Kidney Disease Patients With AnemiaNCT02780726Astellas Pharma Inc56
已完成
3 期
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With AnemiaESA-naive Hemodialysis Chronic Kidney Disease Patients With AnemiaNCT02780141Astellas Pharma Inc75
已完成
3 期
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With AnemiaChronic Kidney DiseaseNCT02964936Astellas Pharma Inc100
已完成
1 期
ASP1517 Pharmacokinetics Study in Anemia Patients on HemodialysisAnemiaHemodialysisRenal ImpairmentNCT01083888Astellas Pharma Inc12