Back to resultsEfficacy and Safety of Dapagliflozin in Children With Proteinuria
Primary Purpose
Proteinuria
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Proteinuria focused on measuring proteinuria, SGLT2i
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dapagliflozin treatment
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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）
Full Information
NCT ID
NCT04534270
First Posted
August 27, 2020
Last Updated
June 17, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04534270
Brief Title
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
Official Title
Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
proteinuria, SGLT2i
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks
Primary Outcome Measure Information:
Title
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin
Description
Urine will be collected for 24 hours and total urinary protein will be detected
Time Frame
From baseline to weeks 4
Secondary Outcome Measure Information:
Title
The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin
Description
Urine will be collected for 24 hours and total urinary protein will be detected
Time Frame
From baseline to weeks 12
Title
The change in eGFR after a 12 weeks treatment with dapagliflozin
Description
eGFR are repeated measurement data and will be evaluated by Schwartz formula（k*height（cm)/creatinine(umol/L), k=36.5）
Time Frame
Measured at baseline, weeks 4, weeks 8, weeks 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
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