Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in estimated glomerular filtration rate (eGFR) values from baseline
研究概览
简要总结
This randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (CKD) progression in patients with CKD stages 2 or/and 3.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (eGFR) between 30-89 ml/min/1.73 m2) at the time of the baseline visit.
- •Patients with and without type 2 diabetes.
- •Patients with or without proteinuria.
- •Age: ≥ 18 years.
排除标准
- •Type 1 diabetes.
- •Patients with eGFR ˂30 ml/min/1.73 m
- •Patients with known hepatic cell failure.
- •Decompensated heart requiring acute management.
- •Active malignancy.
- •Planned coronary or surgical interventions.
- •Known hypersensitivity to study medications.
- •Chronic inflammation, trauma, or infection.
- •Pregnant or lactating women.
- •Patients already on metformin or a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
- •Any of the study treatments labeled contraindications.
研究组 & 干预措施
Metformin treatment group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy.
干预措施: Metformin (Drug)
Metformin treatment group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy.
干预措施: Control (Other)
Empagliflozin treatment group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy.
干预措施: Empagliflozin (Drug)
Empagliflozin treatment group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy.
干预措施: Control (Other)
Control group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.
干预措施: Control (Other)
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR) values from baseline
时间窗: Period of 12 months
This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.
次要结局
- Change in albumin or protein excretion values from baseline(Period of 12 months)
研究者
Bassant Maher Mahboub
Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate.
Tanta University