Dapagliflozin to lower albuminuria in adolescents with early chronic kidney disease
Official title: Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial
Run by Centenario Hospital Miguel Hidalgo · NCT07405216 · Data updated 2026-11-12
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 |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Centenario Hospital Miguel Hidalgo Academic / other |
| Locations | 1 site (Aguascalientes, Aguascalientes) |
| Status | Recruiting |
| Started | April 23, 2026 |
| Main results expected | May 30, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07405216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: dr.jmag@gmail.com
- Phone: +524494632049
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.