Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients with Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- •Serum concentration of erythropoietin (EPO): <50 mIU/mL at screening test 1, 2, or 3
- •Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
- •Subjects meeting any of the following criteria
- •Subjects who has not used erythropoiesis-stimulating agent (ESA) ≥ eight weeks from screening test 1
- •Subjects who has used ESA, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria A) to C).
- •A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)
- •Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.
- •<Criteria for ND subjects>
- •CKD subjects who never received dialysis and do not need to receive dialysis during the study period.
- •Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 13.0 g/dL.
- •Subjects with an eGFR at screening test 1 ≥ 15 mL/min/1.73m^2 to < 45 mL/min/1.73m^
- •<Criteria for HD subjects>
- •Subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent.
- •Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 12.0 g/dL.
排除标准
- •Subjects with anemia other than that caused by CKD.
- •Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
- •Subjects with immune disorder with severe inflammation
- •Subjects with uncontrolled secondary hyperparathyroidism
- •Subjects who already had or will have a kidney transplantation
- •Subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. Or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1
- •Subjects with congestive heart failure
- •Subjects with a medical history of thrombotic disease in the six months from screening test 1
- •Subjects with uncontrolled blood pressure; SBP > 170 mmHg or DBP > 100 mmHg at screening test 1 (ESA present, screening tests 1 and 2), (HD subject, evaluated before dialysis)
研究组 & 干预措施
Step2-2:6mg in non-dialysis subject
干预措施: TS-143 (Drug)
Step1:1mg in non-dialysis subject
干预措施: TS-143 (Drug)
Step2-1:1mg in hemodialysis subjects
干预措施: TS-143 (Drug)
Step3-1:11㎎ in hemodialysis subjects
干预措施: TS-143 (Drug)
Step3-2:11㎎ in non-dialysis subject
干预措施: TS-143 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 8 days
To evaluate the safety of TS-143 given single administration in CKD patients by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Urinary excretions of unchanged form (ng/mL)
时间窗: 24 hours
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Serum EPO concentration
时间窗: 4 days
Reticulocyte count
时间窗: 7 days
Plasma concentrations of unchanged form (ng/mL)
时间窗: 7 days
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Plasma vascular endothelial growth factor (VEGF) concentration
时间窗: 4 days
次要结局
未报告次要终点