Efficacy and Safety of Dapagliflozin in Children With Proteinuria

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

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

Study Overview

• Status: Completed
• Conditions: Proteinuria
• Intervention / Treatment: Drug: Dapagliflozin

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin treatment	Drug: Dapagliflozin; Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: proteinuria; SGLT2i
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: EASODICWP.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No