Cystone for Treatment of Nephrolithiasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
研究概览
简要总结
We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.
详细描述
Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.
Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values < 0.05 were deemed significant.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine
- •Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.
- •Medically effective birth control if fertile female
- •Able to comply with protocol
排除标准
- •Subjects under age 18 years
- •Obstructing stones
- •Urinary Tract Infection that cannot be cleared with single course of antibiotic
- •Subjects who decline to provide informed consent
研究组 & 干预措施
Cystone then sugar pill
Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks
干预措施: Cystone (Drug)
Cystone then sugar pill
Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks
干预措施: Sugar Pill (Placebo) (Drug)
Sugar pill then Cystone
Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks
干预措施: Cystone (Drug)
Sugar pill then Cystone
Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks
干预措施: Sugar Pill (Placebo) (Drug)
Open-label Cystone
All subjects will receive Cystone for 46 weeks in the open-label period.
干预措施: Cystone (Drug)
结局指标
主要结局
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
时间窗: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
时间窗: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
时间窗: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
24 Hour Urinary Cystine Excretion
时间窗: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Stone Density as Measured by Agatston Score Via Computerized Tomography
时间窗: Baseline, approximately 52 weeks after baseline
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Volume of Kidney Stones as Measured on Computerized Tomography
时间窗: Baseline, approximately 52 weeks after baseline
Measurement of kidney stone volume in cubic millimeters.
次要结局
- Change in Stone Burden as Assessed by Radiologist at One Year(Baseline, approximately 52 weeks after baseline)