Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Phase 4

Completed

• Conditions: Proteinuria
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT04534270
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Primary Completion: 2021-12-30
• Status Verified: 2022-02
• Study Completion: 2022-03-30
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapagliflozin treatment	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin	From baseline to weeks 4	Urine will be collected for 24 hours and total urinary protein will be detected

Secondary Outcome Measures

Name	Time	Method
The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin	From baseline to weeks 12	Urine will be collected for 24 hours and total urinary protein will be detected
The change in eGFR after a 12 weeks treatment with dapagliflozin	Measured at baseline, weeks 4, weeks 8, weeks 12	eGFR are repeated measurement data and will be evaluated by Schwartz formula（k\*height（cm)/creatinine(umol/L), k=36.5）

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China