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

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

Study Overview

• Status: Recruiting
• Conditions: Nephrotic Syndrome in Children
• Intervention / Treatment: Drug: ACEI, SGLT-2i

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ayman Hammad, MBBCh,MSc,MD; Phone Number: +20502262307; Email: pediatrics@mans.edu.eg

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Recruiting
      • Mansoura University Children's Hospital
      • Contact: Ayman Hammad, MBBCh,MSc,MD; Phone Number: 20502262307; Email: pediatrics@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Group 1 (ACEI group)	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); Other Names: Captopril, forxiga
Active Comparator: Group 2; Group 2 (combined ACEI and SGLT-2i group)	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); Other Names: Captopril, forxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Ahmed El Refaey, MBBCh,MSc,MD, Mansoura University-Faculty of Medicine-Pediatric

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria; Nephrotic Syndrome; Nephrosis; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Captopril
• Other Study ID Numbers: MS.22.11.2207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing of study protocol
• IPD Sharing Time Frame: 1year
• IPD Sharing Access Criteria: any one
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No