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

Phase 4

Recruiting

• Conditions: Nephrotic Syndrome in Children
• Interventions: Drug: ACEI, SGLT-2i

• Registration Number: NCT06417320
• Lead Sponsor: Mansoura University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-11
• Last Update Submitted: 2024-05-11
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-01
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	ACEI, SGLT-2i	Group 1 (ACEI group)
Group 2	ACEI, SGLT-2i	Group 2 (combined ACEI and SGLT-2i group)

Primary Outcome Measures

Name	Time	Method
Protein free period, eGFR	12 weeks following end of treatment	Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula

Trial Locations

Locations (1)

Mansoura University Children's Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt