Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07214818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Adult Patients With Nephrotic Syndrome: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SGLT2-NS
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: