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

Mansoura University

Status and phase: Enrolling; Phase 4

Conditions: Nephrotic Syndrome in Children

Treatments: Drug: ACEI, SGLT-2i

Study type: Interventional

Funder types: Other

Identifiers

NCT06417320

MS.22.11.2207

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Group 1 (ACEI group)

Treatment:

Drug: ACEI, SGLT-2i

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: ACEI, SGLT-2i