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

Study acronym: SGLT2I-IN-KIDS
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 1, 2026 → Sep 1, 2026
See other at-risk trials from Ann & Robert H Lurie Children's Hospital of Chicago

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Jun 1, 2026 to Sep 1, 2026
    • Study completion pushed from Jul 1, 2026 to Nov 1, 2026
    v7
  2. Minor Primary completion date: Jan 1, 2026 to Jun 1, 2026
    • Study completion date: Jun 1, 2026 to Jul 1, 2026
    v6
  3. Minor Study Identification, Study Status, Oversightv5
  4. Notable Primary completion date: Dec 2027 to Jan 1, 2026
    • Study completion date: Dec 2028 to Jun 1, 2026
    v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Aug 23, 2024
    • Site details revised
    v3
  6. Notable Primary endpoint revisedv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06430684
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Chronic Kidney Diseases, Pediatric Kidney Disease
Related terms Renal Insufficiency, Chronic
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov