NCT02780726已完成3 期
A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis 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
- 56
- 试验地点
- 15
- 主要终点
- Hemoglobin (Hb) Response Rate from Week 18 to Week 24
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal 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
- 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
- •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
- •Subjects who have not received Erythropoieses Stimulating Agents (ESAs):
- •Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment
- •Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.
- •Mean of the subject's two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
- •Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
- •Subjects who have been receiving ESAs:
- •Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment
- •Mean of the subject's two most recent Hb values before randomization during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
- •TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
排除标准
- •Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment
- •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 gastro-paresis
- •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), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, 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 ASP1517
- •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 (ESA Untreated)
Experimental
This group includes subjects who have not received Erythropoieses Stimulating Agents (ESAs). 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 (ESA Untreated)
Experimental
This group includes subjects who have not received ESAs. Study drug will be dosed three times weekly and dose adjustments will be made during the study.
干预措施: roxadustat (Drug)
ASP1517 ESAs Treated Group
Experimental
This group includes subjects who have received ESAs. The treatment was converted from ESAs to study drug. 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 from Week 18 to Week 24
时间窗: Up to Week 24
Hb response defined as average Hb within the target range in this outcome
次要结局
- Change from baseline in the average Hb levels of week 18 to week 24(Baseline and up to Week 24)
- Rate of rise in Hb levels (g/dL/week)(Up to Week 4)
- Hb Response rate(Up to Week 24)
- Proportion of participants who achieve the target Hb level at each week(Up to Week 24)
- Efficacy assessed by total iron binding capacity(Up to Week 24)
- Efficacy assessed by soluble transferrin receptor(Up to Week 24)
- Average Hb levels from week 18 to week 24(Up to week 24)
- Proportion of time points with target Hb levels(Up to Week 24)
- Change from baseline in Hb level at each week(Baseline and Up to Week 24)
- Proportion of participants who achieve the lower limit of the target Hb level(Up to Week 24)
- Time to achieve the lower limit of the target Hb level(Up to Week 24)
- Efficacy assessed by hematocrit(Up to Week 24)
- Efficacy assessed by reticulocytes/ erythrocytes(Up to Week 24)
- Efficacy assessed by Iron (Fe)(Up to Week 24)
- Efficacy assessed by ferritin(Up to Week 24)
- Efficacy assessed by transferrin(Up to Week 24)
- Efficacy assessed by transferrin saturation(Up to Week 24)
- Efficacy assessed by reticulocyte hemoglobin content(Up to Week 24)
- Quality of life assessed by SF-36(Up to Week 24)
- Quality of life assessed by EQ-5D(Up to Week 24)
- Quality of life assessed by FACT-An(Up to Week 24)
- Occurrence of hospitalizations(Up to Week 24)
- Safety assessed by incidence of adverse events(Up to Week 24)
- Number of participants with abnormal Vital signs and/or adverse events related to treatment(Up to Week 24)
- Safety assessed by standard 12-lead electrocardiogram(Up to Week 24)
- Number of participants with abnormal Laboratory values 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 (15)
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