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Infliximab for Immune Checkpoint Inhibitor Associated AKI

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 1 of 3 sites
  2. Notable Recruitment opened Start date: Jul 16, 2026 to Sep 15, 2026 · Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 3 of 10 entries · 1 more Show 4 more changesShow less
    • Start date: Jul 16, 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 10 entries
    • Site details revised at 3 of 3 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multi-center, 1:1 randomized pilot study examining the efficacy and safety of infliximab 5mg/kg x 1 paired with 2 weeks of prednisone 1mg/kg per day for 2 weeks versus standard-of-care glucocorticoid therapy (prednisone 1mg/kg/day x 2 weeks followed by a 4 week taper) on the rate and speed of renal recovery from immune checkpoint inhibitor-associated AKI.
Trial Details
NCT Number NCT07683975
Lead Sponsor Massachusetts General Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Acute Kidney Injury, Acute Interstitial Nephritis
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov