Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
研究概览
简要总结
The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic calcic lithiasis
- •Calculus size lesser than or equal to 2.0 cm (0.79 inches)
- •Signed informed consent
排除标准
- •Calculus size greater than 2,0 cm (0.79 inches)
- •Pregnancy
- •Malignant neoplastic conditions
- •Previous treatment for destruction of calculi in the urinary tract
结局指标
主要结局
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
时间窗: 12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
时间窗: 12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
时间窗: 12 weeks
次要结局
- Calciuria at week 12(12 weeks)
- Uricosuria at week 12(12 weeks)
- Blood Uric acid at week 12(12 weeks)
- Oxaluria at week 12(12 weeks)
- Citraturia at week 12(12 weeks)
- Phosphatemia at week 12(12 weeks)
- Calcemia at week 12(12 weeks)
- Total plasmatic calcium at week 12(12 weeks)
- Blood ionic calcium at week 12(12 weeks)
- Calcium Oxalate crystallization risk at week 12(12 weeks)
- Calcium phosphate activity product at week 12(12 weeks)
- Calcium Oxalate activity product at week 12(12 weeks)
- pH of urine at week 12(12 weeks)
- Presence of adverse effects at any moment of treatment(12 weeks)