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Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease

RecruitingPhase 4Ages 14 Years - 18 YearsAllCentenario Hospital Miguel Hidalgo
NCT07405216 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration, adaptive podocytopathy, and persistent albuminuria at early stages of disease. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated nephroprotective effects in adult populations with CKD, including reductions in albuminuria and slowing of disease progression, independent of diabetes status. However, no randomized controlled trials have evaluated the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD and persistent albuminuria. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether treatment with an

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📋 Eligibility rules (as published)
Inclusion Criteria:Age 14-18 years Residence in Aguascalientes Persistent albuminuria (ACR \>30 and \<300 mg/g) Estimated glomerular filtration rate ≥60 mL/min/1.73 m² No identifiable secondary cause (e.g., lupus, diabetes mellitus) Renal biopsy showing adaptive podocytopathy or perihilar focal segmental glomerulosclerosis - Exclusion Criteria: Hypoalbuminemia Nephrotic syndrome Persistent macroalbuminuria (ACR \>300 mg/g) Secondary causes of CKD, including congenital anomalies of the kidney and urinary tract or polycystic kidney disease -
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What it tests

  • Dapagliflozin (10mg Tab)
  • Placebo
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Where

1 site
Instituto de atención Integral de Enfermedades Renales del Estado de Aguascalientes
Aguascalientes, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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