Recruiting
Early Phase 1

Sodium-GLucose CoTransporter 2 Inhibitors

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT06430684

Conditions

Chronic Kidney Diseases

Pediatric Kidney Disease

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 MG

Study Details

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

Conditions

Chronic Kidney Diseases

Pediatric Kidney Disease

Study ID

NCT06430684

Start date

Aug 23, 2024

Status verified date

Aug, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Empagliflozin 10mg daily for 3 months (n=20)

no intervention: Standard of Care

Participants will not take empagliflozin (n=20)

Interventions

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 measure

  • Percentage of participants who complete all study procedures [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Sodium Glucose Co-Transporter 2 Inhibitor
  • SGLT2i
  • Pediatric CKD
  • Feasibility Study
  • Clinical Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-08-19.