NCT07214818 SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
| NCT ID | NCT07214818 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mansoura University |
| Condition | Nephrotic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2026-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2025-11-15 with a primary completion date of 2026-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Moetaza M Soliman, Associate Professor
STUDY CHAIR
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
Frequently Asked Questions
Who can join the NCT07214818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephrotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07214818 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07214818 currently recruiting?
Yes, NCT07214818 is actively recruiting participants. Contact the research team at dr.m.s.binhariz85@gmail.com for enrollment information.
Where is the NCT07214818 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07214818 clinical trial?
NCT07214818 is sponsored by Mansoura University. The principal investigator is Moetaza M Soliman, Associate Professor at Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University. The trial plans to enroll 75 participants.