A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (Neutra4)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 18
- 主要终点
- Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
研究概览
简要总结
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a male or female 18 years of age or older.
- •Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment
- •Documented BKV viremia based on local or central laboratory testing within 10 days
排除标准
- •A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.
- •A BKV plasma viral load of ≥ 10^7 copies/mL.
研究组 & 干预措施
Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
干预措施: MAU868 (Drug)
Cohort 2
Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
干预措施: MAU868 (Drug)
Cohort 3
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
干预措施: MAU868 (Drug)
Placebo Cohort 1, 2, 3
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
干预措施: Placebo (Other)
结局指标
主要结局
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
时间窗: Study Week 1 - Study Week 36
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
时间窗: Study Week 1 - Study Week 36
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
次要结局
未报告次要终点