Chronic Kidney Diseases, Pediatric Kidney Disease
Conditions
Keywords
Sodium Glucose Co-Transporter 2 Inhibitor, SGLT2i, Pediatric CKD, Feasibility Study, Clinical Trial
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: 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
DRUGEmpagliflozin 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
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who complete all study procedures | 4 years | Compared to the number recruited, how many participants complete the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 3 months | In-clinic systolic blood pressure |
| Serum N-terminal pro-brain natruetic peptide (NT-proBNP) | 3 months | — |
| Urine Albumin to Creatinine Ratio (UACr) | 3 months | — |
| Left Atrial Reservoir Strain | 3 months | Measuring using echocardiography |
Countries
United States
Contacts
CONTACTAlexander J Kula, MD, MHS
Outcome results
None listed