Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease

Sponsor
Children's Hospital of Fudan University
Study ID
NCT04531397
Phase
PHASE4
Status
Withdrawn

Conditions

  • Chronic Kidney Diseases
  • Proteinuria

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • ACEI treatment — DRUG
    ACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d，max 20mg/d), for 24 weeks
  • Dapagliflozin+ACEI treatment — DRUG
    Dapagliflozin will be given 10 mg/day (weight\>30kg) or 5mg/day (weight≤30kg), for 24 weeks ACEI, will be given based on body weight (max 20mg/d), for 24 weeks.

Study Details

We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.

Key Dates

Start date
Jan 1, 2021
Status verified
Dec 2020
Primary completion
Jun 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: ACEI treatment
    Drug: ACEI will be given once daily
  • Experimental: Dapagliflozin+ACEI treatment
    Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily

Primary Outcome Measure

The change in 24 hour proteinuria [ Time Frame: From baseline to week 12 ]

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