A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion 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
- 16
- 试验地点
- 4
- 主要终点
- Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion
研究概览
简要总结
The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.
详细描述
A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Able to comply with study procedures
- •History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone
- •Hyperoxaluria >36mg of oxalate/24-hr
- •May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months
排除标准
- •Uric acid ≥1.5g/24-hr
- •Estimated glomerular filtration rate of < 60 mL/min
- •Positive results from drug urine screen
- •Requires daily vitamin C (defined as >10 days of >300 mg/day)
- •Diagnosis of 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.
- •Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.
- •Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial
- •History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.
- •Taken investigational compound within 30 days prior to the first day of the study
- •Treatment with cholestyramine
- •Average daily dietary intake of <75 mg oxalate per day calculated from diet recalls
研究组 & 干预措施
ALLN-177
Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria
Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days.
干预措施: ALLN-177 (Drug)
结局指标
主要结局
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion
时间窗: 7 days
Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).
次要结局
- Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion(7 days)