Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

August 31, 2023 updated by: Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Dapagliflozin 10mg Tab
Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteinuria
Time Frame: 6 months
Effect of dapagliflozin on proteinuria
6 months
Estimated GFR
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Lipid profile
Time Frame: 6 months
6 months
Body Weight
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 419/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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