The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Discontinuation of SGLT2i
研究概览
简要总结
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.
Recent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.
Our project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.
The goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and < 80 years
- •Diagnosed with acute kidney disease
- •Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²
- •Albuminuria > 100 mg/g or proteinuria > 300 mg/g (adjusted by urine creatinine)
- •Diagnosed with diabetes or chronic kidney disease
排除标准
- •Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days prior to enrollment
- •Patients with type 1 diabetes
- •Receiving aggressive immunosuppressive therapy for glomerulonephritis
- •Obstructive nephropathy
- •Polycystic kidney disease
- •Malignancy within 3 months or expected to undergo aggressive treatment such as chemotherapy, radiation therapy, immunotherapy, or targeted therapy in the future
- •Pregnant or breastfeeding women
- •Clinically assessed as not having recovered from acute kidney injury
- •Clinically assessed as at high risk for complications related to SGLT2 inhibitors
研究组 & 干预措施
SGLT2i
干预措施: dapagliflozin (Drug)
SGLT2i
干预措施: empagliflozin (Drug)
SGLT2i
干预措施: canagliflozin (Drug)
Control
干预措施: Other anti-diabetic drug or no anti-diabetic drug (Other)
结局指标
主要结局
Discontinuation of SGLT2i
时间窗: Day 0 to Day 90
Development of adverse events leading to discontinuation of SGLT2i
Albuminuria
时间窗: Day 28 and Day 90
The changes in albuminuria compared with baseline
次要结局
- Major adverse kidney events(Day 0 to Day 180)
- Major adverse cardiovascular events(Day 0 to Day 180)
- Amputation(Day 0 to Day 180)
- eGFR(Day 28 to Day 84 or Day 28 to Day 168)
- Death(Day 0 to Day 180)