SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

NCT07214818 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: MS.25.08.3285
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SGLT2 inhibitors; Dapagliflozin; Empagliflozin; Proteinuria; Primary Nephrotic Syndrome

Outcome Measures

Primary Outcomes (2)

• 1. Change in Proteinuria (uPCR)

  Change from baseline in urine protein/creatinine ratio

  Baseline to 6 months

• Change in TNF-α Levels

  Change in serum TNF-α measured by ELISA as an exploratory biomarker.

  Baseline to 6 months

Secondary Outcomes (5)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline to 6 months

• Incidence of Adverse Events

  Throughout the 6-month study perio

• Treatment Compliance

  Up to 6 months

• Remission Rate

  Up to 6 months

• Relapse Rate

  Up to 6 months

Study Arms (3)

Dapagliflozin + Standard of Care

EXPERIMENTAL

Drug: Dapagliflozin; Other: Standard Therapy

Empagliflozin + Standard of Care

EXPERIMENTAL

Drug: Empagliflozin; Other: Standard Therapy

Standard of Care Only

ACTIVE COMPARATOR

Standard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor.

Other: Standard Therapy

Interventions

Dapagliflozin DRUG

Dapagliflozin 10 mg PO once daily for 6 months

Dapagliflozin + Standard of Care

Empagliflozin DRUG

Empagliflozin 10 mg PO once daily for 6 month

Empagliflozin + Standard of Care

Standard Therapy OTHER

immunosuppressive therapy and renoprotective agents for 6 months

Dapagliflozin + Standard of Care; Empagliflozin + Standard of Care; Standard of Care Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years). Biopsy-confirmed primary nephrotic syndrome (e.g., idiopathic membranous nephropathy, minimal change disease, focal segmental glomerulosclerosis).
• Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m² using CKD-EPI formula.
• On stable dose of immunosuppressive therapy and renoprotective agents for ≥4 weeks prior to randomization.
• Able to signed informed consent.

You may not qualify if:

• Diagnosis of secondary nephrotic syndrome as : diabetes mellitus, lupus nephritis, and amyloidosis.
• Impaired liver functions (ALT or AST values exceeding 3 folds upper limit of normal (ULN) at the screening visit).
• Glomerular hematuria (red blood cells more than ten cells per high power field (HPF) after routine urinalysis for more than three times in the last 2 weeks).
• History of severe hypersensitivity or contraindications to dapagliflozin or empagliflozine.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology & Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Nephrotic Syndrome; Proteinuria

Interventions

dapagliflozin; empagliflozin; Standard of Care

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Moetaza M Soliman, Associate Professor

  Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

  STUDY CHAIR

• Mustafa O Sharaf El-Deen, Lecturer

  Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Model Details: This interventional study will use a parallel assignment model with three treatment arms: Dapagliflozin plus standard therapy. Empagliflozin plus standard therapy. Standard therapy alone (control). Randomization will be employed to allocate participants to one of the three groups in a 1:1:1 ratio. Due to the nature of the interventions, this is an open-label study, and blinding will not be feasible.

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): September 6, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)