Dapagliflozin to lower albuminuria in adolescents with early chronic kidney disease

Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial

We will test whether a once-daily 10 mg dapagliflozin pill lowers urine albumin in 14–18-year-olds from Aguascalientes who have early chronic kidney disease and persistent microalbuminuria.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 14 Years to 18 Years
• Sex: All
• Sponsor: Centenario Hospital Miguel Hidalgo (Academic / other)
• Locations: 1 site (Aguascalientes, Aguascalientes)
• Trial ID: NCT07405216 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 4 trial comparing once-daily dapagliflozin 10 mg to matched placebo in adolescents aged 14–18 with early-stage CKD (eGFR ≥60 mL/min/1.73 m²) and persistent albuminuria (ACR 30–300 mg/g). Participants must reside in Aguascalientes and have no identifiable secondary cause of CKD, with renal biopsy showing adaptive podocytopathy or perihilar focal segmental glomerulosclerosis. The primary outcome is reduction in albuminuria, and safety and tolerability will be closely monitored. The trial tests whether nephroprotective effects seen with SGLT2 inhibitors in adults extend to adolescents with early kidney disease.

Who should consider this trial

Good fit: Ideal candidates are 14–18-year-olds living in Aguascalientes with persistent microalbuminuria (ACR 30–300 mg/g), eGFR ≥60 mL/min/1.73 m², no secondary causes of CKD, and a compatible renal biopsy.

Not a fit: Patients with nephrotic syndrome, persistent macroalbuminuria (ACR >300 mg/g), hypoalbuminemia, secondary causes of CKD such as diabetes or congenital anomalies, or eGFR <60 mL/min/1.73 m² are unlikely to benefit from this trial.

Why it matters

Potential benefit: If effective, dapagliflozin could reduce albuminuria and help slow progression of CKD in adolescents, potentially delaying the onset of advanced kidney disease in young adulthood.

How similar studies have performed: SGLT2 inhibitors have reduced albuminuria and slowed CKD progression in multiple adult trials, but randomized data in adolescents with early-stage CKD are currently lacking.

Eligibility criteria

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 this trial is running

Aguascalientes, Aguascalientes

• Instituto de atención Integral de Enfermedades Renales del Estado de Aguascalientes — Aguascalientes, Aguascalientes, Mexico (Recruiting)

Study contacts

• Study coordinator: Jose Manuel Arreola Guerra, PhD, MD

Conditions Chronic Kidney Disease; Albuminuria; Adolescent; Sodium Glucose Co-Transporter 2 Inhibitors; Chronic kidney disease; Persistent albuminuria; sodium glucose co-transporter 2 inhibitors