Nephrotic Syndrome, Sodium-Glucose Transporter 2 Inhibitors
Conditions
Brief summary
Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR). The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.
Interventions
DRUGDapagliflozin 10mg Tab
Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* eGFR \> 25 mL/min/1.73m2 * Evidence of primary nephrotic syndrome by renal biopsy * Non-diabetic kidney disease
Exclusion criteria
* Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy * Hepatic impairment \[AST or ALT \>3 times ULN or total bilirubin \>2 times the ULN\] at the time of enrolment * Pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria | 6 months | Effect of dapagliflozin on proteinuria |
| Estimated GFR | 6 months | — |
Other
| Measure | Time frame |
|---|---|
| Lipid profile | 6 months |
| Body Weight | 6 months |
Countries
Egypt
Outcome results
None listed