Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Adult Patients With Nephrotic Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1. Change in Proteinuria (uPCR)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin and empagliflozin) in adult patients with primary nephrotic syndrome. The study will compare three groups: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone.
The primary objective is to assess whether SGLT2 inhibitors reduce proteinuria, maintain remission, and prevent relapse. Secondary objectives include evaluating effects on kidney function (eGFR, serum creatinine) and monitoring safety outcomes.
Participants will continue their baseline standard care and will be followed for 6 months with regular clinical evaluations, laboratory tests, and adverse event monitoring.
详细描述
This randomized, controlled, open-label, single-center clinical trial is designed to investigate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically dapagliflozin and empagliflozin, in adult patients with primary nephrotic syndrome (PNS).
Primary nephrotic syndrome is characterized by significant proteinuria, hypoalbuminemia, and related complications. While traditional therapies such as corticosteroids and immunosuppressive agents remain the cornerstone of treatment, their limited efficacy and adverse effects highlight the need for novel therapeutic options. Evidence from large clinical trials has shown that SGLT2 inhibitors improve renal outcomes in patients with chronic kidney disease and type 2 diabetes; however, their role in primary nephrotic syndrome patients has not been fully established.
In this trial, eligible participants will be adults (≥18 years) with biopsy-confirmed primary nephrotic syndrome and an estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m². Patients with secondary causes of nephrotic syndrome (e.g., diabetic nephropathy, lupus nephritis, amyloidosis), significant liver impairment, or contraindications to SGLT2 inhibitors will be excluded.
Participants will be randomized into three groups:
Group A: Dapagliflozin 10 mg once daily plus standard therapy. Group B: Empagliflozin 10 mg once daily plus standard therapy. Group C: Standard therapy alone (control).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years). Biopsy-confirmed primary nephrotic syndrome (e.g., idiopathic membranous nephropathy, minimal change disease, focal segmental glomerulosclerosis).
- •Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m² using CKD-EPI formula.
- •On stable dose of immunosuppressive therapy and renoprotective agents for ≥4 weeks prior to randomization.
- •Able to signed informed consent.
排除标准
- •Diagnosis of secondary nephrotic syndrome as : diabetes mellitus, lupus nephritis, and amyloidosis.
- •Impaired liver functions (ALT or AST values exceeding 3 folds upper limit of normal (ULN) at the screening visit).
- •Glomerular hematuria (red blood cells more than ten cells per high power field (HPF) after routine urinalysis for more than three times in the last 2 weeks).
- •History of severe hypersensitivity or contraindications to dapagliflozin or empagliflozine.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Dapagliflozin + Standard of Care
干预措施: Dapagliflozin (Drug)
Empagliflozin + Standard of Care
干预措施: Empagliflozin (Drug)
Dapagliflozin + Standard of Care
干预措施: Standard Therapy (Other)
Empagliflozin + Standard of Care
干预措施: Standard Therapy (Other)
Standard of Care Only
Standard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor.
干预措施: Standard Therapy (Other)
结局指标
主要结局
1. Change in Proteinuria (uPCR)
时间窗: Baseline to 6 months
Change from baseline in urine protein/creatinine ratio
Change in TNF-α Levels
时间窗: Baseline to 6 months
Change in serum TNF-α measured by ELISA as an exploratory biomarker.
次要结局
- Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline to 6 months)
- Incidence of Adverse Events(Throughout the 6-month study perio)
- Treatment Compliance(Up to 6 months)
- Remission Rate(Up to 6 months)
- Relapse Rate(Up to 6 months)
研究者
Maged Saleh Mohsen Ban Hariz
Pharmacist
Mansoura University