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

Nephrotic Syndrome in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417320
• Other study ID #: MS.22.11.2207
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: Ayman Hammad, MBBCh,MSc,MD
• Phone: +20502262307
• Email: pediatrics[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

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.

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Nephrotic Syndrome in Children
• Proteinuria

Intervention

Drug:
• ACEI, SGLT-2i
Group 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day) ? Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight=30kg) or 10mg per day (weight >30kg)

Locations

Country	Name	City	State
Egypt	Mansoura University Children's Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein free period, eGFR	Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula	12 weeks following end of treatment