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The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children

RecruitingPhase 3Ages 6 Years - 18 YearsAllChildren's Hospital of Fudan University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: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.
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What it tests

  • Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks,then Standard Treatment alone for12 weeks
  • Standard Treatment alone for 12 weeks ,washout period for 4 weeks ,then Dapagliflozin+Standard Treatment for 12 weeks
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Where

1 site
Children's Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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