Actively Recruiting
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
Led by Children's Hospital of Fudan University · Updated on 2025-06-15
44
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Fudan University
Lead Sponsor
G
Guangzhou Women and Children's Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter, randomized controlled crossover trial aimed to evaluate the efficacy and safety of dapagliflozin in the treatment of hereditary kidney disease with proteinuria in children
CONDITIONS
Official Title
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed hereditary kidney disease diagnosis, either by genetic testing or clinical and pathological findings (family history and high clinical suspicion allowed for Alport syndrome).
- Urinary protein level greater than 0.2 g in 24 hours or protein-to-creatinine ratio above 0.2 mg/mg.
- Estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m² or higher using the Schwartz formula.
- Stable use of renin-angiotensin-aldosterone system inhibitor (RAASi) treatment, including ACEI or ARB, for more than 4 weeks with no dosage changes during the study.
- Willingness to provide informed consent.
You will not qualify if you...
- Use of hormones or immunosuppressive agents within the past 4 weeks.
- Use of SGLT2 inhibitors within the past 4 weeks.
- Diagnosis of diabetes.
- Uncontrolled urinary tract infection.
- Evidence of urinary tract obstruction such as difficulty urinating.
- Blood pressure below the 5th percentile for age, gender, and height.
- History of organ transplantation.
- Presence of tumors.
- Liver disease indicated by ALT/AST levels twice the normal, hepatic encephalopathy, esophageal varices, or portal shunt surgery.
- Medical conditions affecting drug absorption or metabolism, including recent active inflammatory bowel disease, major gastrointestinal surgery, ulcers, bleeding, pancreatic injury, or pancreatitis within the past 6 months.
- Risk of dehydration or volume depletion affecting drug safety or efficacy.
- Participation in other drug trials within the past 4 weeks.
- Blood loss exceeding 400 ml within the past 8 weeks.
- Poor medication compliance or unwillingness to complete the trial.
- Other medical conditions increasing risk from study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
Y
YIHUI ZHAI
CONTACT
W
WEI ZHANG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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