SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- effect of dapagliflozin on renal function
研究概览
简要总结
The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
- The main questions it aims to answer are:
- Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies.
- Investigate the impact of SGLT2i on bone and mineral metabolism in these patients.
Participants will be randomized into two groups :
- Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: will be maintained on their medication.
详细描述
Study sitting: Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
Study design and sample size:
Randomized, controlled trial that will include 100 patients with Lupus nephritis (LN) with an estimated glomerular filtration rate of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
Control group: will be maintained on their medication.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age of patient is more than
- •Patients who are willing to sign informed consent.
- •Patients with SLE diagnosed according to EULAR/ACR classification criteria.
- •Patients with LN according to renal biopsy.
- •Patients with eGFR > 30 ml/min/1.73m2.
排除标准
- •With eGFR <30 ml/min per 1.73 m
- •Who is currently pregnancy or lactation.
- •With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).
- •Refuse to participate in the study or lost follow up.
- •With evidence of urinary obstruction of difficulty in voiding at screening.
- •Who are receiving high dose diuretics or combined angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin II receptor blockers (ARBS).
- •Who have frequent hypotensive episode or systolic blood pressure <100 mmHg. Active malignancy.
- •Active infection including HIV.
- •Any medications that may affect or interact with bone metabolism such as calcitonin, , denosumab, estrogen and fluoride during the last 6 months.
- •Current or previous organ transplantation, or expected to get a kidney transplant within 12 months
研究组 & 干预措施
study group
Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one year.
干预措施: Dapagliflozin tablet (Drug)
control group
Control group: will receive placebo as add on drug once daily with or without food for one year.
干预措施: placebo (Drug)
结局指标
主要结局
effect of dapagliflozin on renal function
时间窗: 1 year
Effect of dapagliflozin on eGFR (ml/ min).
effect of dapagliflozin on kidney function
时间窗: 1 year
Effect of dapagliflozin on s.creatinine (mg/dl).
effect of dapagliflozin on BMD
时间窗: 1 year
Effect of dapagliflozin on osteoporosis using Qct
effect of dapagliflozin on Bone
时间窗: 1 year
Effect of dapagliflozin on bone turnover markers (ng/dl)
effect of dapagliflozin on minerals
时间窗: 1 year
Effect of dapagliflozin on serum calcium and phosphorus (mg/dl)
次要结局
- effect of dapagliflozin on body weight(1 year)
- effect of dapagliflozin on blood pressure(1 year)
研究者
Mohamed Hosny
nephrology specialist at urology and nephrology center (principle investigator)
Mansoura University