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Search / Trial NCT06417320

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

Launched by MANSOURA UNIVERSITY · May 11, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two types of medications, called ACE inhibitors and SGLT-2 inhibitors, on children aged 10 to 18 who have a condition known as nephrotic syndrome. Nephrotic syndrome causes problems with the kidneys, including a condition called proteinuria, where too much protein leaks into the urine. The trial aims to see how these medications can help reduce proteinuria and improve kidney health in these children.

To be eligible for the study, participants must be between 10 and 18 years old, have nephrotic syndrome that has not responded to other treatments, and should not have diabetes or certain other health issues. Before enrolling, their kidney function will be evaluated to ensure it meets specific criteria. If a child joins the trial, they will receive close monitoring and care from medical professionals throughout the study. This research is important because it could lead to better treatment options for nephrotic syndrome in children.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Ahmed El Refaey, MBBCh,MSc,MD

Study Director

Mansoura University-Faculty of Medicine-Pediatric

About Mansoura University

Mansoura University is a prestigious academic institution located in Egypt, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, it leverages its extensive resources and expertise in various fields of healthcare to facilitate innovative research initiatives aimed at improving patient outcomes. The university collaborates with a network of healthcare professionals and researchers to conduct high-quality clinical trials, focusing on addressing critical health challenges through rigorous scientific methodologies. Its dedication to ethical research practices and adherence to regulatory standards underscores its role as a leader in the medical research community.

Locations

Mansoura, Dakahlia, Egypt

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0