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

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

Recruiting
12-25 years
All
Phase N/A

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Overview

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

Eligibility

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 details
    Chronic Kidney Diseases
    Pediatric Kidney Disease

NCT06430684

Ann & Robert H Lurie Children's Hospital of Chicago

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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