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

Last updated: May 11, 2024
Sponsor: Mansoura University
Overall Status: Active - Recruiting

Phase

4

Condition

Focal Segmental Glomerulosclerosis

Nephropathy

Nephrotic Syndrome

Treatment

ACEI, SGLT-2i

Clinical Study ID

NCT06417320
MS.22.11.2207
  • Ages 10-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 oraspartate 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 thestudy protocol.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: ACEI, SGLT-2i
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Mansoura University Children's Hospital

    Mansoura, Dakahlia 35516
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.