Heart surgery patients may get kidney protection from old iron drug
NCT ID NCT04633889
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called deferoxamine can prevent acute kidney injury in adults undergoing heart surgery. The drug works by removing excess iron, which is thought to damage the kidneys during surgery. About 320 participants will receive either the drug or a placebo before their operation to see if it reduces kidney complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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320 people
The number who actually took part.
- Started
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Apr 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years 2. Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass 3. AKI risk score ≥6 at the time of screening 4. Written informed consent from the patient or surrogate Exclusion Criteria: 1. 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 2. Advanced chronic kidney disease (eGFR \<15 ml/min/1.73m2 or end-stage kidney disease receiving RRT) 3. Hemoglobin \<8 g/dL (closest value in the prior 3 months) 4. Fever (temperature ≥38⁰C) in the last 48h 5. Suspected or confirmed bacteremia, endocarditis, or pyelonephritis 6. Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or CT scan in the last 7d 7. Positive COVID-19 test within previous 10d 8. Chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in DEFEAT-AKI) 9. Known hypersensitivity to deferoxamine 10. Taking prochlorperazine 11. Severe hearing loss 12. Pregnant or breastfeeding 13. Prisoner 14. Concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine 15. Surgery to be performed under conditions of circulatory arrest 16. Receiving extracorporeal membrane oxygenation 17. Durable ventricular assist device (VAD) prior to surgery (does not include Impella device or intra-aortic balloon pump) 18. Any condition which, in the judgement of the investigator, might increase the risk to the patient 19. Conflict with other research studies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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