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

Ann & Robert H Lurie Children's Hospital of Chicago

Status and phase: Enrolling; Early Phase 1

Conditions: Chronic Kidney Diseases; Pediatric Kidney Disease

Treatments: Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06430684

K23DK138313 (U.S. NIH Grant/Contract)

SGLT2I-IN-KIDS

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin 10 MG

Standard of Care

No Intervention group

Description:

Participants will not take empagliflozin (n=20)