Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines.
研究概览
简要总结
The role of Dapagliflozin in the improvement in CKD in both diabetic and non-diabetic patients has been evaluated in the past. SGLT2i have also been found to be beneficial in NAFLD patients in improving the liver function parameters. It is also known that cirrhotic patients are at a higher risk of developing CKD at 1 year when compared to non cirrhotics. With this study we aim to study the role Dapagliflozin in cirrhotic patients in reducing the development of CKD, its impact on cirrhotic cardiomyopathy and its role in improvement of metabolic profile and liver related outcomes.
详细描述
Hypothesis: Investigator hypothesise that Use of Dapagliflozin in NAFLD-Cirrhotic patients with moderate ascites will prevent progression and development of chronic kidney disease, ameliorate metabolic dysfunction and facilitate resolution of ascites by its renoprotective, cardioprotective and metabolic effects
Aim: To evaluate the efficacy of Dapagliflozin in NAFLD-cirrhotic patients with moderate ascites in preventing progression and development of CKD
Methodology:
Study population:
- Age > 18 years <70 years
- Patient with NAFLD associated cirrhosis and moderate ascites
- Stable eGFR-(>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × [serum creatinine (mg/dL)]-0. 858 × [age]-0. 167 × [0.822 if patient is female] × [serum urea nitrogen concentration (mg/dL)]-0.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years <70years
- •Patient with NAFLD associated cirrhosis and moderate ascites
- •Stable eGFR-(>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × [serum creatinine (mg/dL)]-
- •858 × [age]-
- •167 × [0.822 if patient is female] × [serum urea nitrogen concentration (mg/dL)]-
- •Valid Informed written consent
排除标准
- •Hospitalized patients
- •CTP-C patients
- •Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
- •History of organ transplantation
- •Refractory Ascites
- •Type 1 DM
- •History of hypoglycemic symptoms in the last 2 months
- •Recurrent UTI
- •Patient with HCC or portal vein thrombosis
- •Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •History of fracture in the preceding year
- •Severe Hyponatremia (Na <125 MEq/L)
- •Pregnancy or Lactating mother
- •Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- •MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- •Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
- •Mixed ascites (additional etiology of ascites apart from portal hypertension)
- •Any severe extra hepatic condition including respiratory and cardiac failure
- •Acute-on-chronic liver failure as per the APASL criteria
- •Refusal to give consent
研究组 & 干预措施
Dapagliflozin+Standard of Care
Dapagliflozin
干预措施: Dapagliflozin (Drug)
Dapagliflozin+Standard of Care
Dapagliflozin
干预措施: Standard of Care (Other)
Standard of Care
Standard of Care
干预措施: Standard of Care (Other)
结局指标
主要结局
Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines.
时间窗: 1 year
次要结局
- Change in eGlomerular filtration rate (eGFR) at 6 months.(6 months)
- Number of participants Discontinuing drug due to adverse effects.(1 year)
- Number of participants with resolution of ascites - partial or complete at 3 months.(3 months)
- Number of participants with resolution of ascites - partial or complete at 6 months.(6 months)
- Number of participants developing Chronic Kidney Disease.(6 months)
- Improvement in eGlomerular filtration rate (eGFR) at 3 months.(3 months)
- Change in eGlomerular filtration rate (eGFR) at 12 months.(12 months)
- Number of participants with resolution of ascites - partial or complete at 12 months.(12 months)
- Number of participants developing acute kidney disease at 3 months.(3 months)
- Number of participants developing acute kidney disease at 6 months.(6 months)
- Number of participants developing acute kidney disease at 12 months.(12 months)