Effect of Sodium Glucose Transporter 2 Inhibitor Empagliflozin on Proteinuria and Kidney Disease Progression in Patients With Non-diabetic Glomerulonephritis- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- protein to creatinine ratio
研究概览
简要总结
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes. one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
详细描述
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes.The favourable cardiovascular effects include increased diuresis , reduction of blood pressure and reduction of hospitalisation for heart failure one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤75 years.
- •Urinary protein excretion > 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
- •On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
- •Who signed informed consent.
- •Women of Child-Bearing Potential (WOCBP) used an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy was minimized.
排除标准
- •a) Diagnosis of type 1 or type 2 diabetes mellitus b) Urinary protein excretion of less than 500 mg/g and eGFR < 30 ml/min
- •1.7m2 c) Active malignancy d) Any medication, surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the last six months; Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; Pancreatic injury or pancreatitis within the last six months.
- •e) Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
- •f) Evidence of urinary tract obstruction. g) History of hypersensitivity or contraindications to empagliflozin. h) Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data.
- •i) Participation in any clinical investigation within 3 months prior to initial dosing.
- •j) History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •k) Pregnancy or breastfeeding.
研究组 & 干预措施
Group 1: Empagliflozin
25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin
干预措施: Empagliflozin 25 MG (Drug)
Group 2:
25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo
干预措施: placebo (Drug)
结局指标
主要结局
protein to creatinine ratio
时间窗: 3 months
measurement of urinary protein to creatinine ratio as a marker of proteinuria
次要结局
- Decline of glomerular filtration rate(3 months)
研究者
Tarek Samy Abdelaziz
Professor
Kasr El Aini Hospital