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

NCT06417320 | Recruiting Phase 4

• 1 other identifier: MS.22.11.2207
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:

1. 1.Proteinuria
2. 2.Renal survival indices

Conditions

Nephrotic Syndrome in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 (ACEI group)

Drug: ACEI, SGLT-2i

Group 2

ACTIVE COMPARATOR

Group 2 (combined ACEI and SGLT-2i group)

Drug: ACEI, SGLT-2i

Interventions

ACEI, SGLT-2i DRUG

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)

Also known as: Captopril, forxiga

Group 1; Group 2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Children's Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Angiotensin-Converting Enzyme Inhibitors; Captopril; dapagliflozin

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ahmed El Refaey, MBBCh,MSc,MD

  Mansoura University-Faculty of Medicine-Pediatric

  STUDY DIRECTOR

Central Study Contacts

Ayman Hammad, MBBCh,MSc,MD

CONTACT

+20502262307; pediatrics@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1year
• Access Criteria: any one

Locations

EG (1)