NCT02780141已完成3 期
A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 47
- 主要终点
- Hemoglobin (Hb) Response rate
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis 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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean of the subjects' two most recent Hb values during the Screening Period must be ≤10.0 g/dL with an absolute difference ≤1.0 g/dL between the two values
- •Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
- •Female subject must either:
- •Be of non-childbearing potential:
- •post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- •documented surgically sterile Or, if of childbearing potential,
- •Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
- •And have a negative pregnancy test at Screening
- •And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
- •Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- •Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- •Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
- •Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
排除标准
- •Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- •Concurrent autoimmune disease with inflammation that could impact erythropoiesis
- •History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis
- •Uncontrolled hypertension
- •Concurrent congestive heart failure (NYHA Class III or higher)
- •History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
- •Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- •Concurrent other form of anemia than renal anemia
- •Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
- •Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment
- •Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- •Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment
- •Having undergone a kidney transplantation
- •Having a previous history of treatment with ASP
- •History of serious drug allergy including anaphylactic shock
- •Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
研究组 & 干预措施
ASP1517 Low dose Group
Experimental
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
干预措施: roxadustat (Drug)
ASP1517 High dose Group
Experimental
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
干预措施: roxadustat (Drug)
结局指标
主要结局
Hemoglobin (Hb) Response rate
时间窗: Up to Week 24
Hb response is defined as reaching target values for Hb and change of Hb from baseline
次要结局
- Average Hb level from Week 18 to 24(Week 18 to 24)
- Time to achieve the lower limit of the target Hb level(Up to Week 24)
- Change from baseline in the average Hb level from Week 18 to 24(Baseline and Weeks 18 to 24)
- Proportion of participants with the target Hb level from Week 18 to 24(Week 18 to 24)
- Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment(Up to Week 4)
- Proportion of measurement points with the target Hb level(Up to Week 24)
- Proportion of participants with the target Hb level at each week(Up to Week 24)
- Proportion of participants with the lower limit of the target Hb level(Up to Week 24)
- Change from baseline in Hb levels to each week(Baseline and Up to Week 24)
- Average reticulocyte level(Up to Week 24)
- Average hematocrit level(Up to Week 24)
- Average iron (Fe) level(Up to Week 24)
- Average transferrin level(Up to Week 24)
- Average transferrin saturation level(Up to Week 24)
- Number of hospitalizations(Up to Week 24)
- Safety assessed by standard 12-lead electrocardiogram(Up to Week 24)
- Average ferritin level(Up to Week 24)
- Average soluble transferrin receptor level(Up to Week 24)
- Average reticulocyte hemoglobin content level(Up to Week 24)
- Duration of hospitalizations(Up to Week 24)
- Safety assessed by incidence of adverse events(Up to Week 24)
- Average total iron binding capacity level(Up to Week 24)
- Quality of life assessed by FACT-An(Up to Week 24)
- Number of participants with abnormal Laboratory values and/or adverse events related to treatment(Up to Week 24)
- Quality of life assessed by EQ-5D-5L(Up to Week 24)
- Number of participants with abnormal Vital signs and/or adverse events related to treatment(Up to Week 24)
- Plasma concentration of unchanged ASP1517(Up to Week 24)
研究者
研究点 (47)
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