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OpenTrials
Completed

NCT Number: NCT06026787

Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

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.

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Sodium-Glucose Transporter 2 Inhibitors Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

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

Primary outcomes

  1. Proteinuria

    Time frame: 6 months

    Effect of dapagliflozin on proteinuria

  2. Estimated GFR

    Time frame: 6 months

Other outcomes

  1. Lipid profile

    Time frame: 6 months

  2. Body Weight

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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