Feasibility Trial of Sodium-GLucose CoTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
NCT ID: NCT06430684
Last Updated: 2025-02-14
Study Results
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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RECRUITING
EARLY_PHASE1
40 participants
INTERVENTIONAL
2024-08-23
2026-06-01
Brief Summary
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1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
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
* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Empagliflozin 10mg daily for 3 months (n=20)
Empagliflozin 10 MG
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
Standard of Care
Participants will not take empagliflozin (n=20)
No interventions assigned to this group
Interventions
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Empagliflozin 10 MG
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diabetes
* Pregnancy
* Recipient of solid organ transplant
* history of chemotherapy or stem cell transplant
* moderate to severe persistent asthma
* liver disease
* class 2 or greater obesity
* inability to follow study procedures due to cognitive impairment
* obstructive uropathy or requirement for intermittent urinary catheterization
* systolic blood pressure \<100mgHg
* orthostatic hypotension
* current use of an SGLT2i
* anticipated need for titration of anti-hypertensives within 3 months
* active use of any immunosuppressive medications
* lack of clearance by primary nephrologist for participation
12 Years
25 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Alexander Kula
Assistant Professor of Pediatrics (Nephrology)
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SGLT2I-IN-KIDS
Identifier Type: -
Identifier Source: org_study_id
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