Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change in 24 hour proteinuria
研究概览
简要总结
We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.
详细描述
Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 years to 18 years；
- •Urinary protein excretion > 200 mg in a 24-hr urine collection；
- •Without any immunosuppressant medications such as corticosteroids, CNIs and so on；
- •Estimated GFR ≥ 60 ml/min/1.73m2（estimated with Schwartz formula）；
- •No history of diabetes；
- •On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month；
- •Willing to sign informed consent.
排除标准
- •Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis;
- •Blood pressure less than 5th percentile of the same gender, age, and height;
- •Uncontrolled urinary tract infection at screening;
- •At risk for dehydration or volume depletion;
- •Evidence of hepatic disease: an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
- •History of organ transplantation, cancer, liver disease;
- •Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •History of active inflammatory bowel disease within the last six months;
- •Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- •Pancreatic injury or pancreatitis within the last six months;
- •Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
研究组 & 干预措施
ACEI treatment
Drug: ACEI will be given once daily
干预措施: ACEI treatment (Drug)
Dapagliflozin+ACEI treatment
Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily
干预措施: Dapagliflozin+ACEI treatment (Drug)
结局指标
主要结局
The change in 24 hour proteinuria
时间窗: From baseline to week 12
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
次要结局
- The change in 24 hour proteinuria(From baseline to week 24)
- The change in albumin from baseline to week 24(Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24)
- The change in eGFR (estimated glomerular filtration rate) from baseline to week 24(Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24)
- The change blood pressure from baseline to week 24(Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24)
- The change in body weight from baseline to week 24(Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24)
- The number of hypoglycemia episodes during the treatment(From baseline to week 24)