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

• Status: Withdrawn
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Angiotensin-Converting Enzyme Inhibitors; Dapagliflozin

Criteria

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.