Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease (SGLT2I-IN-KIDS)

August 18, 2026 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Empagliflozin 10mg daily for 3 months (n=20)
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
No Intervention: Standard of Care
Participants will not take empagliflozin (n=20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who complete all study procedures
Time Frame: 4 years
Compared to the number recruited, how many participants complete the study
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 3 months
In-clinic systolic blood pressure
3 months
Serum N-terminal pro-brain natruetic peptide (NT-proBNP)
Time Frame: 3 months
3 months
Urine Albumin to Creatinine Ratio (UACr)
Time Frame: 3 months
3 months
Left Atrial Reservoir Strain
Time Frame: 3 months
Measuring using echocardiography
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLT2I-IN-KIDS
  • K23DK138313 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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