Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Sponsor
Ain Shams University
Study ID
NCT06026787
Phase
PHASE4
Status
Completed

Conditions

  • Nephrotic Syndrome
  • Sodium-Glucose Transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
Aug 2023
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Arm
    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.
  • No Intervention: Control Arm
    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.

Primary Outcome Measure

Proteinuria [ Time Frame: 6 months ]

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