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Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.

NCT05966818 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-08-01

No results posted yet for this study

Summary

Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism.

The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.

Conditions

  • Nephrotic Syndrome

Interventions

DRUG

Dapagliflozin and Standard therapy (ACEI or ARB).

Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).

DRUG

Standard Therapy (ACEI or ARB).

Standard Therapy which include either ACEI or ARB for 24 weeks.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Nagwa A. Sabri, Professor · Department of Clinical Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-01-01
Completion
2024-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966818 on ClinicalTrials.gov