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NCT06026787 Clinical Trial

Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:
Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06026787
Other study ID # MS 419/2023
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2023

Study information
Verified date August 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Ain Shams University Hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other Lipid profile 6 months
Other Body Weight 6 months
Primary Proteinuria Effect of dapagliflozin on proteinuria 6 months
Primary Estimated GFR 6 months
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