Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-03-30

Brief Summary

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

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Detailed Description

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Conditions

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Proteinuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapagliflozin treatment

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No