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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChildren's Hospital of Fudan University

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

44 Participants
are divided into 2 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