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Heart surgery patients may get kidney protection from old iron drug

NCT ID NCT04633889

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

320 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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