Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
DEFEAT-AKI
2 other identifiers
interventional
320
1 country
3
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2024
CompletedResults Posted
Study results publicly available
January 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedMay 4, 2026
April 1, 2026
3.4 years
November 12, 2020
November 13, 2025
April 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury
Composite outcome that includes any of the following: 1. Urine output \<0.5 ml/kg/h for ≥6 consecutive hours within the first 48h or until the Foley catheter is removed, whichever occurs first 2. Increase in serum creatinine ≥0.3 mg/dl within the first 48h 3. Increase in serum creatinine ≥50% within 7 days 4. Receipt of renal replacement therapy within 7 days
7 days
Secondary Outcomes (10)
Renal Tubular Injury
3 days
Number of Participants With Major Adverse Kidney Events
7 days
Number of Participants With Postoperative Myocardial Injury
2 days
Number of Participants With Atrial Fibrillation or Atrial Flutter
7 days
Number of Participants With Prolonged Mechanical Ventilation
24 hours
- +5 more secondary outcomes
Study Arms (2)
Deferoxamine
EXPERIMENTALDeferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
Placebo
PLACEBO COMPARATORNormal saline (240mL) intravenous infusion over 12 hours
Interventions
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass
- AKI risk score ≥6 at the time of screening
- Written informed consent from the patient or surrogate
You may not qualify if:
- AKI, defined as any of the following:
- Increase in serum creatinine ≥0.3 mg/dl in 48h
- Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
- Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
- Receipt of renal replacement therapy (RRT) within 7d
- Advanced chronic kidney disease (eGFR \<15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
- Hemoglobin \<8 g/dL (closest value in the prior 3 months)
- Fever (temperature ≥38⁰C) in the last 48h
- Suspected or confirmed bacteremia, endocarditis, or pyelonephritis
- Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or CT scan in the last 7d
- Positive COVID-19 test within previous 10d
- Chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in DEFEAT-AKI)
- Known hypersensitivity to deferoxamine
- Taking prochlorperazine
- Severe hearing loss
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
Sharma S, Leaf DE. Iron Chelation as a Potential Therapeutic Strategy for AKI Prevention. J Am Soc Nephrol. 2019 Nov;30(11):2060-2071. doi: 10.1681/ASN.2019060595. Epub 2019 Sep 25.
PMID: 31554656BACKGROUNDScurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1.
PMID: 38689404DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Leaf, MD, MMSc
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
David E. Leaf, MD, MMSc
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Harvard Medical School
Study Record Dates
First Submitted
November 12, 2020
First Posted
November 18, 2020
Study Start
April 13, 2021
Primary Completion
August 26, 2024
Study Completion (Estimated)
August 1, 2026
Last Updated
May 4, 2026
Results First Posted
January 26, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share