SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

NCT ID: NCT07214818

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-09-06

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.

Detailed Description

This randomized, controlled, open-label, single-center clinical trial is designed to investigate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically dapagliflozin and empagliflozin, in adult patients with primary nephrotic syndrome (PNS).

Primary nephrotic syndrome is characterized by significant proteinuria, hypoalbuminemia, and related complications. While traditional therapies such as corticosteroids and immunosuppressive agents remain the cornerstone of treatment, their limited efficacy and adverse effects highlight the need for novel therapeutic options. Evidence from large clinical trials has shown that SGLT2 inhibitors improve renal outcomes in patients with chronic kidney disease and type 2 diabetes; however, their role in primary nephrotic syndrome patients has not been fully established.

In this trial, eligible participants will be adults (≥18 years) with biopsy-confirmed primary nephrotic syndrome and an estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m². Patients with secondary causes of nephrotic syndrome (e.g., diabetic nephropathy, lupus nephritis, amyloidosis), significant liver impairment, or contraindications to SGLT2 inhibitors will be excluded.

Participants will be randomized into three groups:

Group A: Dapagliflozin 10 mg once daily plus standard therapy. Group B: Empagliflozin 10 mg once daily plus standard therapy. Group C: Standard therapy alone (control).

All groups will continue to receive stable doses of background immunosuppressive therapy and renoprotective agents as part of standard of care.

The study duration will be 6 months. Baseline demographics, clinical data, and laboratory parameters will be collected. Follow-up assessments will include proteinuria (urine protein-to-creatinine ratio), serum albumin, serum creatinine, eGFR, uric acid, total cholestrol, liver enzyme(AST,ALT), TNF-α, complete blood count and serum sugar level. Clinical outcomes such as remission, relapse, and adverse events will be recorded.

The primary outcomes are changes in proteinuria, TNF-α levels, and rates of remission and relapse. Secondary outcomes include changes in kidney function (serum creatinine, eGFR), safety profile, and treatment compliance.

This study is expected to provide novel insights into the therapeutic role of SGLT2 inhibitors in primary nephrotic syndrome and may guide future clinical practice in the management of this condition.

Conditions

Nephrotic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin + Standard of Care

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin 10 mg PO once daily for 6 months

Standard Therapy

Intervention Type: OTHER

immunosuppressive therapy and renoprotective agents for 6 months

Empagliflozin + Standard of Care

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10 mg PO once daily for 6 month

Standard Therapy

Intervention Type: OTHER

immunosuppressive therapy and renoprotective agents for 6 months

Standard of Care Only

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

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: OTHER

immunosuppressive therapy and renoprotective agents for 6 months

Interventions

Dapagliflozin

Dapagliflozin 10 mg PO once daily for 6 months

Intervention Type: DRUG

Empagliflozin

Empagliflozin 10 mg PO once daily for 6 month

Intervention Type: DRUG

Standard Therapy

immunosuppressive therapy and renoprotective agents for 6 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Maged Saleh Mohsen Ban Hariz

Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moetaza M Soliman, Associate Professor

Role: STUDY_CHAIR

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

Mustafa O Sharaf El-Deen, Lecturer

Role: STUDY_DIRECTOR

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

Locations

Urology & Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MS.25.08.3285

Identifier Type: -

Identifier Source: org_study_id