Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Study acronym: DEFEAT-AKI
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital Show 6 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Aug 1, 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Site details revised at 1 of 3 sites
    • Publications: details revised at 2 of 2 entries
  2. Secondary endpoints: details revised at 1 of 10 entriesv21
  3. Study completion pushed from Mar 1, 2026 to Aug 1, 2026v20
  4. Results first posted: Jan 26, 2026v19
  5. Secondary endpoints: 11 to 10v18
Show 16 earlier versionsHide 16 earlier versions
  1. Secondary endpoints: details revised at 4 of 11 entriesv17
  2. Trial status: Completed to Active, Not Recruiting
    • Study completion date: Dec 14, 2024 to Mar 1, 2026
    • Secondary endpoints revised (11)
    v16
  3. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 300 to confirmed 320
    • Study completion date changed from estimate of Jan 1, 2025 to Dec 14, 2024
    v15
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 1, 2024 to Aug 26, 2024
    • Study completion date: Oct 1, 2024 to Jan 1, 2025
    • Site details revised at 3 of 3 sites
    v14
  5. Primary completion date: Jun 1, 2024 to Sep 1, 2024
    • Study completion date: Mar 1, 2025 to Oct 1, 2024
    v13
  6. Study completion date: Aug 1, 2025 to Mar 1, 2025v12
  7. Primary completion date: Jun 1, 2025 to Jun 1, 2024v11
  8. Eligibility criteria shortened, about 1 wordv10
  9. Primary completion date: Dec 2024 to Jun 1, 2025
    • Study completion date: Jan 2025 to Aug 1, 2025
    v9
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2021 to Apr 13, 2021
    • Site details revised at 3 of 3 sites
    v8
  11. Secondary endpoints: 9 to 11
    • Eligibility criteria expanded, about 5 words
    v7
  12. Start date: Feb 2021 to Mar 15, 2021
    • Eligibility criteria expanded, about 3 words
    v6
  13. Secondary endpoints: 8 to 9v5
  14. Eligibility criteria expanded, about 13 wordsv4
  15. Secondary endpoints: details revised at 3 of 8 entriesv3
  16. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.
Trial Details
NCT Number NCT04633889
Lead Sponsor Brigham and Women's Hospital
Collaborators: Massachusetts General Hospital, Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Acute Kidney Injury
Related terms Acute Kidney Injury
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov