Efficacy and Safety of Dapagliflozin in Children With Proteinuria

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin 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; Dapagliflozin

Criteria

Inclusion Criteria:

• Age 6 years to 18 years;

• Urinary protein excretion > 0.2g in a 24-hr urine collection;

• eGFR≥60 ml/min/1.73m2;

• No history of diabetes;

• On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;

Exclusion Criteria:

• Receiving immunosuppressive therapy within three months prior to enrolment.

• Blood pressure less than 5th percentile of the same gender, age, and height -

• Leukocyte and/or nitrite positive urinalysis that is untreated;

• History of organ transplantation, cancer, liver disease;

• Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;

• History of noncompliance to medical regimens or unwillingness to comply with the study protocol.