Evaluating the effects of SGLT-2 inhibitors on kidney function in nephrotic children over 10
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
PHASE4 · Mansoura University · NCT06417320
This study is testing if adding a new type of diabetes medication to standard treatment can help improve kidney function and reduce protein in the urine for children aged 10 to 18 with nephrotic syndrome.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Mansoura University (other) |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06417320 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) in conjunction with ACE inhibitors on proteinuria and renal survival in children aged 10 to 18 years with nephrotic syndrome. The study employs a randomized, double-blind design where participants will receive either oral ACE inhibitors or a combination of ACE inhibitors and SGLT-2 inhibitors daily for a duration of 12 weeks. The primary focus is on measuring changes in proteinuria levels and renal function indices throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 10 to 18 years with nephrotic syndrome who are resistant to standard treatments and have a stable renal function.
Not a fit: Patients with uncontrolled urinary tract infections, significant dehydration risks, or those with a history of organ transplantation or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney function and reduced proteinuria in children suffering from nephrotic syndrome.
How similar studies have performed: While the use of SGLT-2 inhibitors in adults has shown promise, this specific application in pediatric nephrotic syndrome is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura University Children's Hospital — Al Mansurah, Dakahlia Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ayman Hammad, MBBCh,MSc,MD
- Email: pediatrics@mans.edu.eg
- Phone: +20502262307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nephrotic Syndrome in Children