NCT01935856已完成1 期
A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
研究概览
简要总结
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Written informed consent
- •Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening
- •intact PTH value ≥ 240 pg/mL at the screening
- •Corrected serum calcium ≥ 8.4 mg/dL at the screening
排除标准
- •Patients with primary hyperparathyroidism
- •Patients who received cinacalcet within 2 weeks prior to the screening
- •Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
- •Patients who received parathyroidectomy and/or parathyroid intervention
- •Patients with uncontrolled hypertension and/or diabetes
- •Patients with severe heart disorder
- •Patients with severe hepatic disease
- •Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening
- •Patients who have been judged ineligible to participate in the study by the investigator
研究组 & 干预措施
KHK7580
Experimental
干预措施: KHK7580 (Drug)
结局指标
主要结局
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
时间窗: For 19 weeks
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
次要结局
- Profiles of pharmacodynamics(For 4-15 days after every dosing)
- Profiles of pharmacokinetics(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period)
研究者
研究点 (1)
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