Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
Recruiting · NCT07405216 · Interventional (participants receive a specific treatment) · Lead sponsor: Centenario Hospital Miguel Hidalgo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 SGLT2 inhibitor reduces albuminuria in adolescents aged 14 to 18 years with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g) and preserved kidney function. Participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or placebo for six months. The primary outcome is the change in urinary albumin-to-creatinine ratio from baseline to six months. Secondary outcomes include changes in estimated glomerular filtration rate and safety outcomes.
Who can take part
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 -
Where it is running
1 location listed.
- Instituto de atención Integral de Enfermedades Renales del Estado de Aguascalientes - Aguascalientes, Aguascalientes, Mexico