Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0120
Source ID: NCT04531397
Associated Drug: Acei Treatment
Title: Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Proteinuria|Chronic Kidney Diseases
Interventions: DRUG: ACEI treatment|DRUG: Dapagliflozin+ACEI treatment
Outcome Measures: Primary: The change in 24 hour proteinuria, Urine will be collected for 24 hours and total urinary albumin excretion will be measured, From baseline to week 12 | Secondary: The change in 24 hour proteinuria, Urine will be collected for 24 hours and total urinary albumin excretion will be measured, From baseline to week 24|The change in albumin from baseline to week 24, Serum albumin levels are repeated measurement data, 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, 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, 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, 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., From baseline to week 24
Sponsor/Collaborators: Sponsor: Children's Hospital of Fudan University
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2022-12-31
Results First Posted:
Last Update Posted: 2020-12-29
Locations: Children's Hospital of Fudan University, Shanghai, Shanghai, 201102, China
URL: https://clinicaltrials.gov/show/NCT04531397