NCT07405216RecruitingPhase 4
Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 23 Apr 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Diseases
- Chronic kidney disease
- NCT number
- NCT07405216
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 23 Apr 2026 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Nephrotic syndrome
- Secondary causes of CKD, including congenital anomalies of the kidney and urinary tract or polycystic kidney disease -
Other
- Hypoalbuminemia
- Persistent macroalbuminuria (ACR \>300 mg/g)
Who the study is looking for
- 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 -
Age in the registry: 14 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de atención Integral de Enfermedades Renales del Estado de Aguascalientes Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.