Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

  1. History of active inflammatory bowel disease within the last six months;
  2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
  3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
  4. 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.