Assessment of the Renoprotective Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
研究概览
简要总结
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.
详细描述
Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema, and other complications as thrombotic diseases, peritonitis and recurrent infections.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intra-glomerular hypertension, it was hypothesized that Dapagliflozin decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss via a glucose independent hemodynamic mechanism.
The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome.
The study will include 90 patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2. Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m2. They will assigned randomly into 2 groups. Each group will contain 45 patients.
- The first group will receive Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
- The second group will receive the standard therapy (ACEI or ARB).
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
盲法说明
90 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤60 years.
- •Patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥
- •Serum creatinine <3mg/dl (265.2umol/L) and eGFR >30 ml/min/1.73 m
- •Pathological diagnosis with membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS).
- •Absence of any contraindication to dapagliflozin (eGFR less than 30).
- •On a stable dose of an ACEI or ARB for at least 4 weeks prior to randomization or Initiation of ACEI or ARB.
- •Agreed to participate and sign written informed consent.
排除标准
- •Diagnosis of type 1 or type 2 diabetes mellitus.
- •Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease or lupus nephritis.
- •Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- •History of severe hypersensitivity or contraindications to dapagliflozin.
- •History of repeated urinary tract infection or fungal infection.
- •Patients with Hemodynamic instability or Hypotension.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Dapagliflozin group and Standard therapy which include either ACEI or ARB
- The first group (45 patients) will receive Dapagliflozin (Diglifloz) 10 mg orally once daily at any time of day with or without food. Tablets are to be swallowed whole with half a cup of water for 24 weeks and standard therapy which include either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
干预措施: Standard Therapy (ACEI or ARB). (Drug)
Dapagliflozin group and Standard therapy which include either ACEI or ARB
- The first group (45 patients) will receive Dapagliflozin (Diglifloz) 10 mg orally once daily at any time of day with or without food. Tablets are to be swallowed whole with half a cup of water for 24 weeks and standard therapy which include either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
干预措施: Dapagliflozin and Standard therapy (ACEI or ARB). (Drug)
Standard therapy which include either ACEI or ARB
- The second group (45 patients); will receive the standard therapy (ACEI or ARB).
干预措施: Dapagliflozin and Standard therapy (ACEI or ARB). (Drug)
Standard therapy which include either ACEI or ARB
- The second group (45 patients); will receive the standard therapy (ACEI or ARB).
干预措施: Standard Therapy (ACEI or ARB). (Drug)
结局指标
主要结局
Assessment of the effect of Dapagliflozin on Glomerular Filtration Rate (GFR).
时间窗: Change from Baseline eGFR at 6 months
By measuring eGFR.
Assessment of the effect of Dapagliflozin on proteinuria.
时间窗: Change from Baseline Serum Albumin at 6 months
By measuring serum albumin
次要结局
- Assessment of the effect of Dapagliflozin on uric acid.(Change from Baseline Uric acid at 6 months)
- Assessment of the effect of Dapagliflozin on Systolic blood pressure.(Change from Baseline Systolic Blood Pressure at 6 months)
- Assessment of the effect of Dapagliflozin on Diastolic blood pressure.(Change from Baseline Diastolic Blood Pressure at 6 months)
- Assessment of the effect of Dapagliflozin on lipid profile.(Change from Baseline lipid profile at 6 months)
研究者
Amal A. Elkholy
Lecturer of Clinical Pharmacy
Ain Shams University