NCT05161936终止2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年1月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of lumasiran on the percent change in urinary oxalate excretion in patients with recurrent calcium oxalate kidney stone disease.
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
- •Documented diagnosis of recurrent kidney stone disease based on ≥2 stone events with a minimum of 1 stone event within 5 years prior to screening
- •Meets the 24 hour urine oxalate excretion requirements
- •The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate
排除标准
- •Known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones
- •Primary hyperoxaluria
- •Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 at screening
- •Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer
研究组 & 干预措施
Lumasiran Dose 1
Experimental
Participants will be administered lumasiran by subcutaneous (SC) injection.
干预措施: Lumasiran (Drug)
Lumasiran Dose 2
Experimental
Participants will be administered lumasiran by SC injection.
干预措施: Lumasiran (Drug)
Placebo
Placebo Comparator
Participants will be administered placebo by SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in 24-hour Urinary Oxalate From Baseline to Month 6
时间窗: Baseline to Month 6
次要结局
- Percentage of Patients Who Achieve a ≥20% Reduction in 24-hour Urinary Oxalate From Baseline to Month 6(Baseline to Month 6)
- Percent Change in Urinary Calcium Oxalate Supersaturation From Baseline to Month 6(Baseline to Month 6)
研究者
研究点 (1)
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