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

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

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

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• Wuhan Children's Hospital

  collaborator OTHER

• Xuzhou Children Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Children's Hospital of Nanjing Medical University

  collaborator OTHER

• Zhengzhou Children's Hospital, China

  collaborator OTHER

• Xiamen Women's and Children's Hospital

  collaborator UNKNOWN

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

• Maternal and Child Health Care Hospital of Hainan Province

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Xian Children's Hospital

  collaborator OTHER_GOV

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Wuxi Women's & Children's Hospital

  collaborator OTHER

• First People's Hospital of Urumqi

  collaborator UNKNOWN

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• YIHUI ZHAI · Children's Hospital of Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-22

Primary Completion

2026-12-31

Completion

2027-03-31

Countries

• China

Study Locations