Status:
RECRUITING
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
Lead Sponsor:
Children's Hospital of Fudan University
Collaborating Sponsors:
Guangzhou Women and Children's Medical Center
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Conditions:
Pediatric Hereditary Kidney Diseases
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
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
Detailed Description
Chronic kidney disease (CKD) poses a significant public health threat to children, with hereditary kidney diseases exhibiting limited therapeutic efficacy in reducing proteinuria. Global studies have ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of hereditary kidney disease (identification of pathogenic genes through molecular genetic testing; for Alport syndrome, molecular diagnosis is not necessarily required if diagnosed based on clinical and pathological findings; for those with a clear family history and a high clinical suspicion of hereditary kidney disease).
- 24 - hour urinary protein level \> 0.2 g or urinary protein to creatinine ratio (UPCR) \> 0.2 mg/mg.
- Calculate the estimated glomerular filtration rate (eGFR) using the Schwartz formula (36.5 \* height in cm / serum creatinine in μmol/L), with eGFR ≥ 60 ml/min/1.73 m².
- Stable use of the basic treatment drug RAASi (including ACEI/ARB) for more than 4 weeks, and no dosage adjustment during the treatment period.
- Willingness to sign the informed consent form.
Exclusion
- Exclusion applies if any of the following criteria are met:
- Treatment with hormones/immunosuppressive agents within the previous 4 weeks.
- Treatment with SGLT2 inhibitors within the previous 4 weeks.
- Comorbid diabetes.
- Uncontrolled urinary tract infection.
- Evidence of urinary tract obstruction such as dysuria.
- Blood pressure below the 5th percentile for the same gender, age, and height.
- Organ transplantation.
- Tumor.
- Presence of any of the following definite evidence of liver disease: ALT/AST reaching 2 times the normal value, hepatic encephalopathy, esophageal varices, or portal shunt surgery.
- Comorbid medical conditions that may affect drug absorption, distribution, metabolism, and excretion, including but not limited to any of the following: active inflammatory bowel disease within the past 6 months, history of major gastrointestinal surgery (such as gastrectomy, gastroenterostomy, intestinal resection), gastrointestinal ulcer, gastrointestinal or rectal bleeding within the past 6 months, pancreatic injury or pancreatitis within the past 6 months.
- Subjects at risk of dehydration or volume depletion, which may affect drug efficacy or safety.
- Participation in other drug trials within the previous 4 weeks.
- Blood loss exceeding 400 ml within the previous 8 weeks.
- Poor past medication compliance or unwillingness to complete the trial.
- Any other medical conditions that may place the patient at a higher risk due to participation in this study.
Key Trial Info
Start Date :
March 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06890143
Start Date
March 22 2025
End Date
March 31 2027
Last Update
June 15 2025
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102