A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 16
- 主要终点
- Mean urinary oxalate excretion (mg/24 h) following treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent 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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for up to 60 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 and at least one kidney stone within the past 2 years
- •Hyperoxaluria at screening
- •May be taking drugs for the prevention of stone disease
排除标准
- •Hyperuricosuria
- •Glomerular filtration rate < 55 mL/min/1.73m2
- •Hypercalcemia or hypothyroidism
- •Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
- •Treatment with cholestyramine
- •Average daily dietary intake of oxalate <75 mg per day
研究组 & 干预措施
Placebo
Placebo capsules (1, 2 or 5) PO TID
干预措施: Placebo (Drug)
ALLN-177 low dose
ALLN-177 1,500 units/meal PO TID
干预措施: ALLN-177 low dose (Drug)
ALLN-177 mid dose
ALLN-177 3,000 units/meal PO TID
干预措施: ALLN-177 mid dose (Drug)
ALLN-177 high dose
ALLN-177 7,500 units/meal PO TID
干预措施: ALLN-177 high dose (Drug)
结局指标
主要结局
Mean urinary oxalate excretion (mg/24 h) following treatment
时间窗: on 7 days of treatment
次要结局
- Change from baseline in mean urinary oxalate excretion (mg/24 h)(on 7 days of treatment)