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Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years

Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years

Recruiting
10-18 years
All
Phase 4

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Overview

The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:

  1. Proteinuria
  2. Renal survival indices

Description

This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.

Eligibility

Inclusion Criteria:

  • Age between 10 and 18 years old,
  • Nephrotic resistant patients,
  • No history of diabetes,
  • Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
  • Caregivers' acceptance to be enrolled in the study.

Exclusion Criteria:

  • Uncontrolled urinary tract infection at screening,
  • Blood pressure is less than 5th percentile of the same gender, age, height,
  • At risk of dehydration or volume depletion,
  • Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase >2 times the upper limit of normal during screening,
  • History of organ transplantation, cancer, liver disease,
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Study details
    Nephrotic Syndrome in Children

NCT06417320

Mansoura University

26 May 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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