Effect of Dapagliflozin versus standard care on risk of recurrence of kidney stones measured by urinary super-saturation: A Randomised placebo controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formation
研究概览
简要总结
Nephrolithiasis is a common renal disease that frequently recurs and amounts to large disease burden in Indian patients with no effective evidence based preventive medication. A huge number of patients have to undergo different types of surgeries for stone clearance. Despite of getting cleared stone almost 50 percent patients land up with re-stone formation in next 10 years. Patients with multiple stones and / or abnormal urinary super-saturation have high risk of repeated stone formation. Surgical interventions are associated with morbidity, prolonged hospital stay, sepsis or death in few cases. If not managed timely may lead to renal failure. There is no definitive means to prevent or delay the recurrence of stone disease in urinary tract. Sodium-glucose cotransporter-2 (SGLT2, encoded by SLC5A2) inhibitors, a novel class of antidiabetic agents, induce urinary glucose excretion by inhibiting SGLT2 at the S1 and S2 segments of the proximal tubules. Apart from glycaemic control, SGLT2 inhibitors have diverse functions, including blood pressure reduction improved cardiovascular outcomes, renoprotection, lipid improvement, and weight, visceral fat, and serum uric acid level reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with known renal stone disease, after getting stone clearance by either medical expulsive therapy or by endoscopic surgery, Age between 18 to 60 years, Renal stones of the following types: Calcium phosphate, Calcium Oxalate, Uric acid.
排除标准
- •Recurrent stone formers with confirmed alternate diagnoses such as incomplete RTA, Bartter’s, cystinuria, history of surgery in prior 6 weeks, Dehydration, Hemodynamic instability, Critical illness, Lower urinary tract symptoms, Severe renal failure with eGFR less than 45 ml per min, Patient on any SGLT2 inhibitors at the time of enrolment or in previous 3 months, Patient on teriparatide, bisphosphonates, denosumab at the time of enrolment or in previous 6 months, Sepsis or septic shock, Moribund patients with reduced life expectancy, Severe cardiopulmonary disease, Pregnancy and lactation, History of genital infections or urinary tract infections, Primary Hyperparathyroidism, Malignancy, Congenital anomaly of kidney and urinary tract.
结局指标
主要结局
Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formation
时间窗: Baseline and 6 months
次要结局
未报告次要终点
研究者
Vipin Chandra
All india institute of Medical sciences, patna
