NCT06430684RecruitingEarly phase 1
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 May 2024
- Start date
- 23 Aug 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Diseases
- Chronic kidney disease
- NCT number
- NCT06430684
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 40
- From 23 Aug 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recipient of solid organ transplant
- active use of any immunosuppressive medications
Other illness
- Heart Disease
- Diabetes
- history of chemotherapy or stem cell transplant
- liver disease
- inability to follow study procedures due to cognitive impairment
Lab values
- lack of clearance by primary nephrologist for participation
Other
- Pregnancy
- moderate to severe persistent asthma
- class 2 or greater obesity
- 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
Who the study is looking for
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Age in the registry: 12 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.