Dapagliflozin for children with hereditary kidney disease and proteinuria
Official title: The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children: a Prospective, Randomized Crossover Trial
Run by Children's Hospital of Fudan University · NCT06890143 · Data updated 2026-11-12
This trial will test whether adding dapagliflozin to standard ACE inhibitor or ARB therapy reduces protein in the urine of children with hereditary kidney disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 22, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06890143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with a confirmed hereditary kidney disease, measurable proteinuria (24-hour >0.2 g or UPCR >0.2 mg/mg), eGFR ≥60 ml/min/1.73 m², and stable RAAS inhibitor therapy are the intended participants.
✕Probably not a fit
Children with low eGFR (<60 ml/min/1.73 m²), no measurable proteinuria, recent use of immunosuppression, or unstable RAASi dosing are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label, block-randomized crossover Phase 3 trial will enroll 44 children with hereditary kidney disease and proteinuria. Participants are randomized 1:1 to receive dapagliflozin plus stable RAAS inhibitor therapy for 12 weeks followed by a 4-week washout and 12 weeks of RAASi alone, or the reverse sequence. The primary outcome is change in 24-hour urinary protein from baseline to 12 weeks, with secondary outcomes including UPCR, UACR, serum albumin, eGFR, blood pressure, and body weight. Safety and tolerability will be monitored throughout the treatment periods.
Why it matters
Potential benefit: If successful, adding dapagliflozin could lower proteinuria in affected children and potentially slow progression of kidney damage.
How similar studies have gone: Large adult trials have shown dapagliflozin reduces proteinuria and slows CKD progression, but its effectiveness in children with hereditary kidney diseases remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yihui Zhai
- Email: yhzhai@fudan.edu.cn
- Phone: +86-021-64932827
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.