Study of the Cardio Renal Effects of SGLT2 Inhibitors 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
- 84
- 试验地点
- 1
- 主要终点
- Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year
研究概览
简要总结
This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy.
The main objective of this study is to:
To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN).
To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.
详细描述
Study sitting:
Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo. The primary endpoint will be sustained decline in eGFR ≥50%, ESKD, or kidney or cardiovascular death We will follow up all patients for 12 months and compare their results.
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
- Double (Participant, Care Provider)
盲法说明
double blind
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 16 year.
- •Willing to sign informed consent.
- •Diagnosis of SLE according to EULAR/ACR classification criteria.
- •Renal biopsy showed lupus nephritis.
- •Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation.
排除标准
- •Patients with eGFR <30 ml/min per 1.73 m
- •Current pregnancy or lactation.
- •Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
- •Patients refusing to participate in the study or lost follow up.
- •Evidence of urinary obstruction of difficulty in voiding at screening.
- •Patients who are receiving high dose diuretics or combined ACEI, Angiotensin II receptor blockers (ARBS).
- •Patients who have frequent hypotensive episode or SBP <100 mmHg.
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 ye
干预措施: dapagliflozin (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 Compared to Placebo on Renal Function After One Year
时间窗: one year
Effect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein
Cardiovascular Assessment in Two Groups
时间窗: 1 year
Coronary artery calcification will be measured using non-contrast computed tomography (NCCT). The Agatston score, a standardized method for quantifying coronary calcification, will be used to assess and compare baseline and 1-year follow-up measurements between the dapagliflozin and placebo groups.
Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level
时间窗: 1 year
Erythropoietin level will be measured in two groups before and after intervention
Effect of Dapagliflozin Compared to Placebo on Hepcidin Level
时间窗: 1 year
hepcidin level will be measured in two groups before and after intervention
Effect of Dapagliflozin Compared to Placebo on Renal Function
时间窗: 1 year
Effect of Dapagliflozin Compared to Placebo on Renal Function on uric acid after 1 year
次要结局
- Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters(1 year)
- Effect of Dapagliflozin Compared to Placebo on Body Weight(1 year)
研究者
Nourelsabah Mohamed
Nephrology specialist at mansoura urology and nephrology center
Mansoura University