Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Fudan University

Status and phase: Completed; Phase 4

Conditions: Proteinuria

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT04534270

EASODICWP.01

Details and patient eligibility

About

The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.

Enrollment: 23 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Dapagliflozin treatment

Experimental group

Treatment:

Drug: Dapagliflozin