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

Sponsor
Centenario Hospital Miguel Hidalgo
Study ID
NCT07405216
Phase
PHASE4
Status
Recruiting
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Conditions

  • Adolescent
  • Albuminuria
  • Chronic Kidney Disease (Mild to Moderate)
  • Sodium Glucose Co-Transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Adolescents with persistent albuminuria
  • Placebo Comparator: Placebo
    Placebo 10 mg daily

Primary Outcome Measure

Albuminuria [ Time Frame: 2, 4 and 6 months ]

Central Contacts

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