NCT06026787

Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome
• Sodium-Glucose Transporter 2 Inhibitors

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2023-09-07
• Last updated: 2023-09-07

Locations

1 site across 1 country: Egypt