RecruitingPhase 4NCT06417320

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

Sponsor

Mansoura University

Enrollment

60 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Nephrotic Syndrome in Children

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

Eligibility

Min Age: 10 YearsMax Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

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Interventions

DRUGACEI, 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)