A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 22
- 主要终点
- Mean change in urinary oxalate excretion (mg/24h)
研究概览
简要总结
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.
详细描述
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.
Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.
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
- •History of enteric or idiopathic hyperoxaluria or kidney stones
- •Urinary oxalate ≥ 50 mg/24 hours
排除标准
- •Hyperuricosuria
- •Glomerular filtration rate < 45 mL/min/1.73m2
- •Hypercalcemia or hyperthyroidism
- •Autoimmune disorder requiring systemic steroids
- •Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure
研究组 & 干预措施
Placebo
Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
干预措施: Placebo (Drug)
ALLN-177
Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals
干预措施: ALLN-177 (Drug)
结局指标
主要结局
Mean change in urinary oxalate excretion (mg/24h)
时间窗: 28 days
次要结局
- Percent change in urinary oxalate excretion(28 days)
- ≥ 7.5 mg/24 hr decrease in urinary oxalate(28 days)
- ≥ 10 mg/24 hr decrease in urinary oxalate(28 days)
- Time-weighted average urinary oxalate excretion (mg/24h)(28 days)
- Mean change in urinary supersaturation of calcium oxalate(28 days)