MedTrace Logo

SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

NCT07214818 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Nephrotic Syndrome

Interventions

DRUG

Dapagliflozin

Dapagliflozin 10 mg PO once daily for 6 months

DRUG

Empagliflozin

Empagliflozin 10 mg PO once daily for 6 month

OTHER

Standard Therapy

immunosuppressive therapy and renoprotective agents for 6 months

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Moetaza M Soliman, Associate Professor · Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

  • Mustafa O Sharaf El-Deen, Lecturer · Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-07-05
Completion
2026-09-06
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214818 on ClinicalTrials.gov