Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 92
- 试验地点
- 113
- 主要终点
- Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4
研究概览
简要总结
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
详细描述
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent
- •Age 18 years or older
- •Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
- •Urinary oxalate ≥ 50 mg/24 hr
- •Has at least 1 documented kidney stone within 2 years
排除标准
- •Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
- •Has a known genetic, congenital, or other cause of kidney stones
- •Unable or unwilling to discontinue Vitamin C supplementation >200mg daily
- •Cannot establish baseline kidney stone burden
研究组 & 干预措施
Reloxaliase
Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
干预措施: Reloxaliase (Drug)
placebo
placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4
时间窗: 4 weeks
Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging)
时间窗: up to 48 months
Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo
次要结局
- Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24(24 weeks)
- Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4(4 weeks)
- Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones(up to 48 months)
- Change in estimated glomerular filtration rate (eGFR) from baseline(up to 48 months)