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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT04633889

Run by

Brigham and Women's Hospital

People needed

320

Starts

2021-04-13

Expected to finish

2026-08-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Pregnant or breastfeeding
• Prisoner
• Concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine
• Surgery to be performed under conditions of circulatory arrest
• Receiving extracorporeal membrane oxygenation
• Durable ventricular assist device (VAD) prior to surgery (does not include Impella device or intra-aortic balloon pump)
• Any condition which, in the judgement of the investigator, might increase the risk to the patient
• Conflict with other research studies

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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