NCT01806610撤回2 期
A Randomized, Placebo-controlled Trial of BPS804 on Safety and Tolerability in Patients With Late-stage Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Occurrence of adverse events after a single administration of BPS804
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
详细描述
This study was previously posted by Novartis and was transferred to Ultragenyx in February 2021.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BPS804
Experimental
Single dose BPS804 administration.
干预措施: BPS804 (Drug)
Placebo
Placebo Comparator
Single dose placebo administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of adverse events after a single administration of BPS804
时间窗: 17 weeks
Adverse events will be counted within each treatment and study part. The numbers and percentages of adverse events will be tabulated by body system, preferred term, and severity.
次要结局
- PK of BPS804 in serum: terminal elimination half-life(Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing)
- PK of BPS804 in serum: observed maximum serum concentration following drug administration(Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing)
- Pharmacokinetic (PK) of BPS804 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration(Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing)
- PK of BPS804 in serum: area under the serum concentration-time curve from time zero to infinity(Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing)
- PK of BPS804 in serum: time to reach the maximum concentration after drug administration(Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing)
- Concentration of BPS804 in dialysate 48 hours after dosing(Day 3, 48 hours post dosing)
研究者
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