drugset / Trial / NCT07214818

SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

NCT07214818

Phase 2/3 Recruiting 75 enrolled Mansoura University
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized controlled clinical trial aims to evaluate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin and empagliflozin) in adult patients with primary nephrotic syndrome. The study will compare three groups: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone. The primary objective is to assess whether SGLT2 inhibitors reduce proteinuria, maintain remission, and prevent relapse. Secondary objectives include evaluating effects on kidney function (eGFR, serum creatinine) and monitoring safety outcomes. Participants will continue their baseline standard care and will be followed for 6 months with regular clinical evaluations, laboratory tests, and adverse event monitoring.

Timeline

Start
2025-11-15
Primary completion
2026-07-05
Completion
2026-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral
Subject Empagliflozin Small molecule 10 mg Oral

Indications