Clinical trial

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

Name

MS.22.11.2207

Description

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

Trial arms

Trial start

2023-06-01

Estimated PCD

2025-01-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

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)

Arms:

Group 1, Group 2

Other names:

Captopril, forxiga

Size

Primary endpoint

Protein free period, eGFR

12 weeks following end of treatment

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

Mansoura University

Product

ACEI

Indication

Nephrotic Syndrome in Children