NCT06890143 The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
| NCT ID | NCT06890143 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Pediatric Hereditary Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-03-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 44 participants in total. It began in 2025-03-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
YIHUI ZHAI
STUDY DIRECTOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06890143 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Pediatric Hereditary Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06890143 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 44 participants.
Is NCT06890143 currently recruiting?
Yes, NCT06890143 is actively recruiting participants. Contact the research team at yhzhai@fudan.edu.cn for enrollment information.
Where is the NCT06890143 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06890143 clinical trial?
NCT06890143 is sponsored by Children's Hospital of Fudan University. The principal investigator is YIHUI ZHAI at Children's Hospital of Fudan University. The trial plans to enroll 44 participants.
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