Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 63
- 主要终点
- Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
详细描述
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population 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 or older
- •History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
- •Urinary Oxalate ≥ 50mg/24h
排除标准
- •Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- •Unable or unwilling to discontinue Vitamin C supplementation
研究组 & 干预措施
ALLN-177
ALLN-177 3,750 units per capsule
干预措施: ALLN-177 (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 1-4
时间窗: 4 weeks
Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
次要结局
- Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4(4 weeks)