Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04534270

Enrollment

Registered

2020-09-01

Start date

2020-07-06

Completion date

2022-03-30

Last updated

2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proteinuria

Keywords

proteinuria, SGLT2i

Brief summary

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

Interventions

DRUGDapagliflozin

Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight\>30kg), for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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）

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026