CTRI/2024/11/076246尚未招募不适用
Effect of Dapagliflozin on Progression, Prevention of Complications and Mortality in Patients of Chronic Kidney Disease
Pt B D Sharma PGIMS Rohtak Haryana India1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Dapagliflozin on slowing disease progression and preventing complication in patients of CKD.
研究概览
简要总结
In India, it has been seen that mean years of developing cardiac complication is decade
earlier as compared to the those in western population, moreover cardiovascular
complications are the most common cause of death in patients of CKD. Though SGLT-2
inhibitors have shown a beneficial effect in decreasing progression of disease in western
population butthere are very few studies done on Indian population. Hence our study is
planned to see the effect of dapagliflozin on progression of disease in patients of CKD
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All who are above the age of 18 years and less than 65 years of age at the time of consent.
- •â€¢ eGFR ≥30 and ≤90 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 or if there is evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1.
排除标准
- •Age less than 18years or more than 65years • Pregnancy • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment • History of organ transplantation • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor • Type 1 diabetes mellitus • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment • Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12weeks prior to enrolment • Any malignancy • Chronic Urinary Tract Infection.
结局指标
主要结局
To evaluate the effect of Dapagliflozin on slowing disease progression and preventing complication in patients of CKD.
时间窗: At baseline , then at 4weeks, then at 13 weeks, then at 26 weeks
次要结局
- To evaluate its effect on various renal and cardiovascular parameters in patients of CKD(• Percentage change from baseline in 24hr proteinuria)
研究者
Aviral Dua
Pt B D Sharma PGIMS, Rohtak, Haryana
研究点 (1)
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