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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK138313 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.
Study Procedures Include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Empagliflozin 10mg daily for 3 months (n=20) |
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| Standard of Care | No Intervention | Participants will not take empagliflozin (n=20) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who complete all study procedures | Compared to the number recruited, how many participants complete the study | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | In-clinic systolic blood pressure | 3 months |
| Serum N-terminal pro-brain natruetic peptide (NT-proBNP) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander J Kula, MD, MHS | Contact | 312-227-6160 | alexkula@luriechildrens.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Urine Albumin to Creatinine Ratio (UACr) | 3 months |
| Left Atrial Reservoir Strain | Measuring using echocardiography | 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |