NCT06417320

Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on: 1. Proteinuria 2. Renal survival indices

Detailed description

This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.

Conditions

• Nephrotic Syndrome in Children

Interventions

Type	Name	Description
DRUG	ACEI, SGLT-2i	Group 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day) ❖ Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight≤30kg) or 10mg per day (weight \>30kg)

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-01-01
• Completion: 2025-08-01
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: Egypt