Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Overview
- Phase
- Early Phase 1
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percentage of participants who complete all study procedures
Overview
Brief Summary
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:
- Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Exclusion Criteria
- •Heart Disease
- •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
Arms & Interventions
Treatment
Empagliflozin 10mg daily for 3 months (n=20)
Intervention: Empagliflozin 10 MG (Drug)
Standard of Care
Participants will not take empagliflozin (n=20)
Outcomes
Primary Outcomes
Percentage of participants who complete all study procedures
Time Frame: 4 years
Compared to the number recruited, how many participants complete the study
Secondary Outcomes
- Systolic Blood Pressure(3 months)
- Urine Albumin to Creatinine Ratio (UACr)(3 months)
- Left Atrial Reservoir Strain(3 months)
- Serum N-terminal pro-brain natruetic peptide (NT-proBNP)(3 months)
Investigators
Alexander Kula
Assistant Professor of Pediatrics (Nephrology)
Ann & Robert H Lurie Children's Hospital of Chicago