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临床试验/CTRI/2022/04/042032
CTRI/2022/04/042032尚未招募2 期

Efficacy and safety of oral dapagliflozin in reducing proteinuria in children with proteinuric chronic kidney diseases.

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1) Chronic kidney disease (CKD) stage 1 or 2 (eGFR greater than 60 mL/minute per 1.73 m2) 2)Nephrotic range proteinuria on two consecutive evaluations (greater than 1 g/m2 daily; greater than 40 mg/m2 /hr ) 3) On weight-appropriate dose of either an ACE-inhibitor or aldosterone receptor blocker for greater than or equal to 4 weeks, with dose not expected to change over the next 12 weeks 4) If on immunosuppression, doses not expected to change over next 12 weeks

排除标准

  • 1) Blood pressure below 5th percentile for age, sex and height percentile
  • 2) Clinical or biochemical feature(s) of hypovolemia
  • 3) Body mass index less than -2 standard deviation scores for age and sex
  • 4) Diabetes mellitus or hyperglycemia
  • 5) Hyponatremia (serum sodium less than 135 mEq/L)
  • 6) Serum albumin less than 2 g/dL
  • 7) Hepatic transaminases (AST/ALT) greater than 3 times upper limit of normal
  • 8) Pancreatic injury or pancreatitis within the last 6 months
  • 9) Known inflammatory bowel disease; major gastrointestinal tract surgery; gastrointestinal ulcers; and/or gastrointestinal or rectal bleeding in last 6 months
  • 10) History of noncompliance to medical regimens or unwillingness to comply

研究者

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