We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.
Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 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.
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The change in 24 hour proteinuria
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
Time frame: From baseline to week 12
The change in 24 hour proteinuria
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
Time frame: From baseline to week 24
The change in albumin from baseline to week 24
Serum albumin levels are repeated measurement data
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in eGFR (estimated glomerular filtration rate) from baseline to week 24
eGFR will be evaluated using Schwartz formula (eGFR=k\*height(cm)/serum creatinine(umol/L)), k=36.5), and eGFR are repeated measurement data
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change blood pressure from baseline to week 24
Blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP) are repeated measurement data
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in body weight from baseline to week 24
Body weight are repeated measurement data and will be measured in the morning
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The number of hypoglycemia episodes during the treatment
Patients will be asked to measure fasting blood glucose every morning and record the data by their parents during the treatment period. Hypoglycemia is defined as glucose level less than 3.9mmol/L.
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Time frame: From baseline to week 24