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The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Group 1 (ACEI group) |
|
| Group 2 | Active Comparator | Group 2 (combined ACEI and SGLT-2i group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACEI, SGLT-2i | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Protein free period, eGFR | Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula | 12 weeks following end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayman Hammad, MBBCh,MSc,MD | Contact | +20502262307 | pediatrics@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El Refaey, MBBCh,MSc,MD | Mansoura University-Faculty of Medicine-Pediatric | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children's Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
sharing of study protocol
1year
any one
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D002216 | Captopril |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
|
| D020164 | Chemical Actions and Uses |
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |