Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534270
• Other study ID #: EASODICWP.01
• Status: Completed
• Phase: Phase 4
• Start date: July 6, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Proteinuria

Intervention

Drug:
• Dapagliflozin
Dapagliflozin will be given 5mg per day (weight=30kg) or 10mg per day (weight>30kg), for 12 weeks

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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