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

NCT06430684 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this study

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

Conditions

  • Chronic Kidney Diseases
  • Pediatric Kidney Disease

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2026-06-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430684 on ClinicalTrials.gov