Comparison of the renoprotective effect of SGLT-2 inhibitor with RAAS inhibitor versus RAAS inhibitor alone in Chronic Kidney Disease”: A Randomized Controlled Trial in the Tribal Population of Gujarat.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The research hypothesizes that combined SGLT-2 inhibitor and RAAS inhibitor therapy may outperform RAAS inhibitor monotherapy in preserving kidney
研究概览
简要总结
This randomized controlled trial aims to compare the renoprotective effects of SGLT-2 inhibitors (dapagliflozin) combined with RAAS inhibitors versus RAAS inhibitors alone in stage 3 chronic kidney disease (CKD) patients from the tribal population of Gujarat. The study will evaluate changes in eGFR, proteinuria, blood pressure, metabolic parameters, and cardiovascular outcomes over a 12-month period. With 130 participants, the trial addresses a critical gap in Indian data on combination therapy. Findings may guide CKD management strategies in underrepresented communities, offering potential improvements in disease progression, metabolic control, and overall clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent form prior to any study specific procedures 2) Female or male aged more than and equal to 18 years at the time of enrollment 3) CKD Stage 3a/b based on eGFR more than and equal to 30 and less than and equal to 60 mL/min/1.73m2 (CKD-EPI formula) or Proteinuria more than and equal to 1+ on standard urine dipstick correspond to UPCR more than 30 mg/g.
排除标准
- •Hypersensitivity (Known allergy) to SGLT2 inhibitor or RAAS Blocker.
- •Genitourinary infection (if not treated successfully).
- •CKD stage 4 or ESRD based on S.Cr measured eGFR ( CKD EPI ).
- •Kidney transplant patient.
- •Pregnant and lactating women.
- •Participation in another interventional clinical trial within 4 weeks prior to baseline and during the current trial.
- •New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment.
- •Type 1 diabetes mellitus (T1D).
结局指标
主要结局
The research hypothesizes that combined SGLT-2 inhibitor and RAAS inhibitor therapy may outperform RAAS inhibitor monotherapy in preserving kidney
时间窗: 1 year
function, as measured by:
时间窗: 1 year
1. Slower eGFR deterioration
时间窗: 1 year
2. More pronounced albuminuria reduction
时间窗: 1 year
次要结局
- 1. Superior hypertension management(2. Favourable metabolic effects)
研究者
Dr Abhishek Bhupatbhai Bhalala
Zydus Medical College and Hospital