Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Sodium-Glucose Transporter 2 Inhibitors; Nephrotic Syndrome

Treatments: Drug: Dapagliflozin 10mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06026787

MS 419/2023

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dapagliflozin Arm

Experimental group

Description:

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.

Treatment:

Drug: Dapagliflozin 10mg Tab

Control Arm

No Intervention group

Description:

This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs.