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

PHASE3RecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 22, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Pediatric Hereditary Kidney Diseases
Interventions
DRUG

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

"①Dapagliflozin+Standard Treatment for 12 weeks. Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily,with dose adjustment based on body weight: 5 mg/day for participants ≤30 kg; 5 mg/day initially (first week), then increased to 10 mg/day for participants \>30 kg Standard Treatment:standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.),This combined therapy will be administered for 12 weeks.~② Washout period for 4 weeks Participants should maintenance RAASi therapy while discontinuing dapagliflozin.~③Standard Treatment alone for an additional 12 weeks. To ensure compliance, all participants are required to complete a daily medication log.If any adverse events (AEs) occur, appropriate clinical interventions will be promptly implemented"

DRUG

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

"①Standard Treatment for 12 weeks Standard Treatment:Standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy alone for 12 weeks.(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.)~②Washout period for 4 weeks Participants should maintenance RAASi therapy while discontinuing dapagliflozin.~③Dapagliflozin+Standard Treatment for 12 weeks Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily,with dose adjustment based on body weight: 5 mg/day for participants ≤30 kg; 5 mg/day initially (first week), then increased to 10 mg/day for participants \>30 kg.This combined therapy will be administered for 12 weeks To ensure compliance, all participants are required to complete a daily medication log.If any adverse events (AEs) occur, appropriate clinical interventions will be promptly implemented"

Trial Locations (1)

201102

RECRUITING

Children's Hospital of Fudan University, Shanghai

All Listed Sponsors
collaborator

Guangzhou Women and Children's Medical Center

OTHER

collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

collaborator

Wuhan Children's Hospital

OTHER

collaborator

Xuzhou Children Hospital

OTHER

collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Kunming Children's Hospital

OTHER

collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

collaborator

Children's Hospital of Nanjing Medical University

OTHER

collaborator

Zhengzhou Children's Hospital, China

OTHER

collaborator

Xiamen Women's and Children's Hospital

UNKNOWN

collaborator

Guiyang Maternity and Child Health Care Hospital

OTHER

collaborator

Maternal and Child Health Care Hospital of Hainan Province

OTHER

collaborator

Children's Hospital of The Capital Institute of Pediatrics

OTHER

collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Xian Children's Hospital

OTHER_GOV

collaborator

The Second Hospital of Hebei Medical University

OTHER

collaborator

Wuxi Women's & Children's Hospital

OTHER

collaborator

First People's Hospital of Urumqi

UNKNOWN

lead

Children's Hospital of Fudan University

OTHER