Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

NCT06430684 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: SGLT2I-IN-KIDSK23DK138313
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who complete all study procedures

  Compared to the number recruited, how many participants complete the study

  4 years

Secondary Outcomes (4)

• 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

  3 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Standard of Care

NO INTERVENTION

Participants will not take empagliflozin (n=20)

Interventions

Empagliflozin 10 MG DRUG

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

Treatment

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander J Kula, MD, MHS

CONTACT

312-227-6160; alexkula@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics (Nephrology)

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)