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Clinical Trial Details

Trial ID: L0293
Source ID: NCT06155604
Associated Drug: Dapagliflozin 10mg Tab
Title: SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Lupus Nephritis|Chronic Kidney Diseases
Interventions: DRUG: Dapagliflozin 10mg Tab|DRUG: Standard maintenance therapy
Outcome Measures: Primary: eGFR reduction, Incidence of eGFR reduction by 30% or more at 24 months, 24 months | Secondary: eGFR, Changes in eGFR over time, 24 months|Urine protein-to-creatinine (UPC) ratio, Changes in urine protein-to-creatinine (UPC) ratio over time, 24 months|End-stage kidney disease (ESKD), Incidence rates of end-stage kidney disease (ESKD), 24 months|Fasting glucose, Changes in fasting glucose over time, 24 months|Hba1c, Changes in Hba1c over time, 24 months|Lipids, Changes in lipids over time, 24 months|Anti-dsDNA, Changes in anti-dsDNA over time (measured by ELIZA), 24 months|C3, Changes in C3 over time (measured by nephelometry), 24 months|Memory B cells, Changes in memory B cells over time (measured by flow cytometry), 24 months|miR-148a, Changes in miR-148a over time (measured by qPCR using blood samples), 24 months|BACH1, Changes in BACH1 over time (measured by qPCR using blood samples), 24 months|BACH2, Changes in BACH2 over time (measured by qPCR using blood samples), 24 months|PAX5, Changes in PAX5 over time (measured by qPCR using blood samples), 24 months|Clinical relapses, Occurrence of clinical relapses (renal and extra-renal relapses), 24 months|Urinary tract infection, Incidence rates of urinary tract infection, 24 months|Ketoacidosis, Incidence rates of ketoacidosis, 24 months|genital infection, Incidence rates of genital infection, 24 months|Acute kidney injury, Incidence rates of acute kidney injury, 24 months
Sponsor/Collaborators: Sponsor: The University of Hong Kong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-04
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2024-12-16
Locations: Queen Mary Hospital, Hong Kong, Hong Kong
URL: https://clinicaltrials.gov/show/NCT06155604