Assessment of Safety and Efficacy of Sodium Glucose Co-transporter 2 Inhibitors Among Lupus Nephritis Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Renal Function Tests:
研究概览
简要总结
The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.
详细描述
SLE is a chronic debilitating autoimmune disorder that involves multiple organ systems either simultaneously or sequentially with relapsing and remitting course. The word 'Lupus' is a Latin term which means wolf.
Lupus nephritis (LN) is one of the common complications in patients with SLE and influences overall outcome of these patients. About two-thirds of patients with SLE have renal disease at some stage which is a leading cause of mortality in these patients.
Manifestations of LN vary from asymptomatic urinary abnormalities to rapidly progressive crescentic glomerulonephritis to end-stage renal disease (ESRD).
Recently, metabolic modulation approach has become a hot spot in the management of SLE. Increased glucose metabolism in immune cells has been reported in patients with SLE.
Repurposing metformin, an old anti diabetic drug, has the potential to reduce the risk of lupus flare in randomized controlled trials. A recent crossover study implied that peroxisome proliferator-activated receptor-gamma agonists might decrease cardiovascular risk in patients with SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Patients aged more than 18 year.
- •Patients with confirmed SLE according to EULAR/ACR classification criteria.
- •Patients with LN ( persistent proteinuria > 2 gm per day or greater than 3+ by dipstick, and/or cellular casts including red cell, hemoglobin, granular, tubular or mixed & "active urinary sediment" (>5 RBC/hpf, >5 WBC/hpf in the absence of infection, or cellular casts limited to RBC or WBC casts )
- •Patient with e GFR > 25 ml/min/1.73m2 by CKD-EPI equation.
排除标准
- •Patients with an allergy or intolerance to Dapagliflozin or any prior SGLT2i exposure within 1 month before screening.
- •Medical history of chronic disease (Severe respiratory distress, gastrointestinal tract lesions & chronic liver disease)
- •Patients with recurrent genitourinary infections.
- •Patient with proteinuria < 2gm.
- •Patient who show response to immune therapy in proteinuria reduction > 50%.
- •Patient with Lupus in induction phase.
- •Patient on steroids > 30 mg daily dose.
- •Patients with diabetes mellitus.
- •Patients with severe infection requiring antibiotics within 1 month before screening.
- •Patients with malignant diseases.
- •Pregnant or breast-feeding women.
- •Patients with eGFR < 25 ml/min/1.73m2 or undergoing dialysis therapy
研究组 & 干预措施
Drug as Dapagliflozin 10 mg orally for 6 months is given
25 lupus nephritis patients will receive SGLT2is as dapagliflozin 10mg beside there usual treatment of lupus for 6 months
干预措施: Dapagliflozin 10mg Tab orally once daily (Drug)
结局指标
主要结局
Renal Function Tests:
时间窗: 6 months
1. Measurement of serum urea level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months. 2. Measurement of serum creatinine level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months. 3. Measurement of serum uric acid level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
次要结局
未报告次要终点
研究者
Marwa Ahmed Mohamed Ahmed Waly
Head of Nephrology Department
Ain Shams University