About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 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
Treatment groups
Sponsors and collaborators
Children's Hospital of Fudan University
Lead sponsor
Guangzhou Women and Children's Medical Center
Collaborator
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Shandong Provincial Hospital
Collaborator
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
Wuhan Children's Hospital
Collaborator
Xuzhou Children Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Kunming Children's Hospital
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
Children's Hospital of Nanjing Medical University
Collaborator
Zhengzhou Children's Hospital, China
Collaborator
Xiamen Women's and Children's Hospital
Collaborator
Guiyang Maternity and Child Health Care Hospital
Collaborator
Maternal and Child Health Care Hospital of Hainan Province
Collaborator
Children's Hospital of The Capital Institute of Pediatrics
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Xian Children's Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Wuxi Women's & Children's Hospital
Collaborator
First People's Hospital of Urumqi
Collaborator