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临床试验/CTRI/2025/12/098403
CTRI/2025/12/098403尚未招募不适用

Effect of Dapagliflozin versus standard care on risk of recurrence of kidney stones measured by urinary super-saturation: A Randomised placebo controlled study

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2026年1月1日最近更新:

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

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Vipin Chandra

All india institute of Medical sciences, patna

研究点 (1)

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