NCT07405216 Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
| NCT ID | NCT07405216 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centenario Hospital Miguel Hidalgo |
| Condition | Chronic Kidney Disease (Mild to Moderate) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-04-23 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07405216 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 18 Years, studying Chronic Kidney Disease (Mild to Moderate). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405216 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07405216 currently recruiting?
Yes, NCT07405216 is actively recruiting participants. Contact the research team at dr.jmag@gmail.com for enrollment information.
Where is the NCT07405216 trial being conducted?
This trial is being conducted at Aguascalientes, Mexico.
Who is sponsoring the NCT07405216 clinical trial?
NCT07405216 is sponsored by Centenario Hospital Miguel Hidalgo. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.