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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Nephrotic Syndrome in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group 1

Group 1 (ACEI group)

Group Type ACTIVE_COMPARATOR

ACEI, SGLT-2i

Intervention Type 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)

Group 2

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

Group Type ACTIVE_COMPARATOR

ACEI, SGLT-2i

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Captopril, forxiga

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No