Nephrotic Syndrome in Children
Conditions
Brief 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
Detailed 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.
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)
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein free period, eGFR | 12 weeks following end of treatment | Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula |
Countries
Egypt
Contacts
Primary ContactAyman Hammad, MBBCh,MSc,MD
Outcome results
None listed