Nephrotic SyndromePhase 2/3SGLT2-NSNCT07214818
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
A Phase 2/3 study testing Dapagliflozin, Empagliflozin and Standard Therapy in people with Nephrotic Syndrome, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Dapagliflozin, Empagliflozin and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 6 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Urology & Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Adult Patients With Nephrotic Syndrome: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Dapagliflozin, Empagliflozin, Standard Therapy
- Keywords
- SGLT2 inhibitors, Dapagliflozin, Empagliflozin, Proteinuria, Primary Nephrotic Syndrome
- Medical subject headings
- Nephrotic Syndrome, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10 mg PO once daily for 6 months
EmpagliflozinDrug
Empagliflozin 10 mg PO once daily for 6 month
Standard TherapyOther
immunosuppressive therapy and renoprotective agents for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + Standard of Care | Experimental | Not described Receives: Drug: Dapagliflozin; Other: Standard Therapy |
| Empagliflozin + Standard of Care | Experimental | Not described Receives: Drug: Empagliflozin; Other: Standard Therapy |
| Standard of Care Only | Active comparator | Standard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor. Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in Proteinuria (uPCR)
Change from baseline in urine protein/creatinine ratio
Measured: Baseline to 6 months
Change in TNF-α Levels
Change in serum TNF-α measured by ELISA as an exploratory biomarker.
Measured: Baseline to 6 months
Secondary outcomes (5)
Change in Estimated Glomerular Filtration Rate (eGFR)
Mean change in eGFR calculated by CKD-EPI formula.
Measured: Baseline to 6 months
Incidence of Adverse Events
Frequency and severity of adverse effects including infection, gastrointestinal upset, oral candidiasis, and other safety concerns.
Measured: Throughout the 6-month study perio
Treatment Compliance
Proportion of participants with documented adherence to study medication and standard therapy.
Measured: Up to 6 months
Remission Rate
Proportion of patients achieving remission
Measured: Up to 6 months
Relapse Rate
Proportion of patients experiencing relapse
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start15 Nov 2025
- Primary completion5 Jul 2026 (estimated)
- Study completion6 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Saleh Mohsen Ban Hariz, Mansoura University
- Investigators
- Moetaza M Soliman, Associate Professor, Study chair, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura UniversityMustafa O Sharaf El-Deen, Lecturer, Study director, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214818
- Sponsor's protocol ID
- MS.25.08.3285
- Acronym
- SGLT2-NS
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Adult Patients With Nephrotic Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07214818
- Acronym / sponsor ID
- SGLT2-NS / MS.25.08.3285
- Conditions
- Nephrotic Syndrome
- Keywords
- SGLT2 inhibitors, Dapagliflozin, Empagliflozin, Proteinuria, Primary Nephrotic Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 6 Sep 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Standard TherapyStandard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin 10 mg PO once daily for 6 months | Drug | Dapagliflozin + Standard of Care |
| EmpagliflozinEmpagliflozin 10 mg PO once daily for 6 month | Drug | Empagliflozin + Standard of Care |
| Standard Therapyimmunosuppressive therapy and renoprotective agents for 6 months | Other | Dapagliflozin + Standard of Care, Empagliflozin + Standard of Care, Standard of Care Only |
Primary outcome
1. Change in Proteinuria (uPCR)
Time frame: Baseline to 6 months
Change from baseline in urine protein/creatinine ratio
Change in TNF-α Levels
Time frame: Baseline to 6 months
Change in serum TNF-α measured by ELISA as an exploratory biomarker.
5 secondary outcomes
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to 6 months
Incidence of Adverse Events
Time frame: Throughout the 6-month study perio
Treatment Compliance
Time frame: Up to 6 months
Remission Rate
Time frame: Up to 6 months
Relapse Rate
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moetaza M Soliman, Associate Professor study chair
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
Mustafa O Sharaf El-Deen, Lecturer study director
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin, Empagliflozin and Standard Therapy in people with Nephrotic Syndrome, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maged S Hariz, PhD Candidate (00201029837454, dr.m.s.binhariz85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in Proteinuria (uPCR) (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.