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

Early Phase 1

Recruiting

• Conditions: Chronic Kidney Diseases; Pediatric Kidney Disease
• Interventions: Drug: Empagliflozin 10 MG

• Registration Number: NCT06430684
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Study Start: 2024-08-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Empagliflozin 10 MG	Empagliflozin 10mg daily for 3 months (n=20)

Primary Outcome Measures

Name	Time	Method
Percentage of participants who complete all study procedures	4 years	Compared to the number recruited, how many participants complete the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States