Dapagliflozin for Protein Leakage in Urine in Teens With Early Kidney Disease
Tests dapagliflozin against placebo in teenagers with early chronic kidney disease and albuminuria.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
Key facts
- Where
- Aguascalientes, MexicoSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 18 years old?
Source: NCT07405216, who can take part
Where in Mexico
- Instituto de atención Integral de Enfermedades Renales del Estado de AguascalientesAguascalientes, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centenario Hospital Miguel Hidalgo
- Trial code
- NCT07405216
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial
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.
Inclusion: 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: Nephrotic syndrome; Secondary causes of CKD, including congenital anomalies of the kidney and urinary tract or polycystic kidney disease -; Hypoalbuminemia; Persistent macroalbuminuria (ACR >300 mg/g).