Efficacy and Safety of Dapagliflozin in Children With Proteinuria

NCT04534270 | Completed Phase 4

• 1 other identifier: EASODICWP.01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proteinuria

Keywords

proteinuria; SGLT2i

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin

  From baseline to weeks 12

• The change in eGFR after a 12 weeks treatment with dapagliflozin

  Measured at baseline, weeks 4, weeks 8, weeks 12

Study Arms (1)

Dapagliflozin treatment

EXPERIMENTAL

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

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

Dapagliflozin treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Proteinuria

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: July 6, 2020
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-02

Locations

CN (1)