Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin 10 MG.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Pediatric Kidney Disease. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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: 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
Interventions
- Drug 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
Primary outcome measures
- Percentage of participants who complete all study procedures [Time frame: 4 years]
Secondary outcome measures (4)
- Systolic Blood Pressure [Time frame: 3 months]
- Serum N-terminal pro-brain natruetic peptide (NT-proBNP) [Time frame: 3 months]
- Urine Albumin to Creatinine Ratio (UACr) [Time frame: 3 months]
- Left Atrial Reservoir Strain [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Exclusion criteria
- Heart Disease
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Identifiers
NCT: NCT06430684 · SGLT2I-IN-KIDS · K23DK138313