A randomized controlled trial to compare the efficacy of combination therapy of SGLT2 inhibitor and ARB to ARB monotherapy on clinical outcomes in patients with CKD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Estimation of EGFR and Urine albumin creatinine ratio
研究概览
简要总结
This study is a randomized, double blinded, parallel group, single centre trial comparing the efficacy of combination therapy of dapagliflozin 10mg daily and telmisartan 40 mg daily for 3 months with telmisartan 40 mg daily alone for 3 months in patients with chronic kidney disease. A total of 78 patients are to be included in the trial. The primary outcome is change in eGFR and urine albumin creatinine ratio which will be measured every month for 3 months. The secondary outcomes are changes in Blood pressure, serum creatinine, fasting glucose, HBa1c, lipid profile and rates of clinical adverse events such as myocardial infarction, stroke or end-stage renal disease at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Gfr greater than 25 ml/min/m2
- •Urine albumin creatinine ratio greater than 30 mg/g with or without hypertension
- •Type 2 Diabetes mellitus
- •Hypertension.
排除标准
- •Patients not willing to give informed consent
- •Patients with end stage renal disease
- •Patients with acute renal failure
- •Patients with albumin creatinine ratio less than 30 mg/g
- •Pregnant and lactating mothers.
结局指标
主要结局
Estimation of EGFR and Urine albumin creatinine ratio
时间窗: Every month for 3 months
次要结局
- Blood pressure, lipid profile, serum creatinine, HbA1c, fasting glucose and rates of clinical adverse events such as myocardial infarction, stroke or end-stage renal disease(3 MONTHS)
研究者
Nithesh Babu R
Saveetha Medical College Hospital