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

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: Chronic Kidney Diseases; Pediatric Kidney Disease
• Intervention / Treatment: Drug: Empagliflozin 10 MG

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Alexander J Kula, MD, MHS; Phone Number: 312-227-6160; Email: alexkula@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Alexander J Kula, MD, MHS; Phone Number: 312-227-6160; Email: alexkula@luriechildrens.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	In-clinic systolic blood pressure	3 months
Serum N-terminal pro-brain natruetic peptide (NT-proBNP)		3 months
Urine Albumin to Creatinine Ratio (UACr)		3 months
Left Atrial Reservoir Strain	Measuring using echocardiography	3 months

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 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): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Clinical Trial; SGLT2i; Feasibility Study; Sodium Glucose Co-Transporter 2 Inhibitor; Pediatric CKD
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; empagliflozin
• 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