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

What this Trial Is About

Chronic kidney disease (CKD) is a significant health issue in Aguascalientes, Mexico, particularly affecting adolescents and young adults. This region shows a high prevalence of CKD linked to reduced nephron development before birth, causing increased kidney stress and persistent protein in the urine early in the disease. Researchers are evaluating whether sodium-glucose cotransporter-2 inhibitors (SGLT2i), which have shown kidney-protective effects in adults, can reduce albuminuria in adolescents with early-stage CKD. The trial is a randomized, double-blind, placebo-controlled study involving adolescents aged 14 to 18 years with persistent microalbuminuria and preserved kidney function. Participants will be randomly assigned in a 2:1 ratio to receive either dapagliflozin 10 mg daily or a matching placebo for six months. All participants will receive nutritional counseling throughout the study. Follow-up visits will happen every two months for clinical assessments and laboratory tests. Participants will undergo screening and baseline evaluations including medical history, lab tests, immune studies, and kidney ultrasound before randomization. During follow-ups, urinary albumin-to-creatinine ratio and kidney function will be monitored along with safety assessments for side effects like low blood pressure or urinary infections. The main outcome is the change in albuminuria over six months, with additional measures of kidney filtration rate and safety. This trial aims to provide important evidence on SGLT2 inhibitors for adolescents with early CKD.

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