Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Phase 4

Completed

• Conditions: Sodium-Glucose Transporter 2 Inhibitors; Nephrotic Syndrome
• Interventions: Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT06026787
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin Arm	Dapagliflozin 10mg Tab	During the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary.

Primary Outcome Measures

Name	Time	Method
Estimated GFR	6 months
Proteinuria	6 months	Effect of dapagliflozin on proteinuria

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt