What side effects are associated with this type of intervention?

The most common treatments for Acute Kidney Injury (AKI) include supportive care, dialysis, and pharmacologic interventions such as iron chelation with agents like Deferoxamine. Known side effects of Deferoxamine include hypotension, allergic reactions, and potential neurotoxicity with long-term use. General side effects of AKI treatments can also include electrolyte imbalances, infection risks from dialysis, and complications related to fluid management.

What prior FDA approvals exist?

The FDA has not approved specific iron chelators like Deferoxamine for the treatment of Acute Kidney Injury (AKI). Current treatments for AKI primarily focus on supportive care, including fluid management, electrolyte balance, and renal replacement therapy if necessary. Research is ongoing to explore the efficacy of iron chelators in preventing AKI, particularly in high-risk scenarios such as cardiac surgery, but no iron chelation therapies have received FDA approval for this indication as of now.

What other types of research exist?

Promising novel alternatives to deferoxamine for iron chelation in AKI patients include newer iron chelators such as deferiprone and deferasirox. These agents have shown potential in reducing iron-mediated kidney injury in various studies. Additionally, research into the use of antioxidants and anti-inflammatory agents, such as N-acetylcysteine and curcumin, is ongoing and may offer complementary benefits in managing AKI.

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Iron Chelator

Deferoxamine for Cardiac Surgery-Associated Acute Kidney Injury (DEFEAT-AKI Trial)

Phase 2

Recruiting

Led By David E. Leaf, MD, MMSc

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass

Must not have

Fever (temperature ≥38⁰C) in the last 48h

Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Summary

This trial is testing whether a medication called deferoxamine can prevent kidney damage in patients having heart surgery. These patients are at risk because surgery can release a lot of iron into their blood, which can harm their kidneys. Deferoxamine helps by removing this excess iron. Deferoxamine has been used to treat conditions where there is too much iron in the body.

Who is the study for?

This trial is for adults over 18 who are at risk of acute kidney injury (AKI) and are undergoing heart surgery with cardiopulmonary bypass. They must have an AKI risk score of ≥6, not be pregnant or breastfeeding, and cannot be in another study that could interfere with this one. People with severe chronic kidney disease, recent infections, fever, or certain conditions like iron overload can't join.

What is being tested?

The trial is testing if Deferoxamine, a drug that removes excess iron from the body (iron chelator), can prevent AKI after heart surgery compared to a placebo (normal saline). It's a phase 2 study where patients are randomly assigned to receive either Deferoxamine or placebo in a double-blind manner—neither they nor the doctors know which one they're getting.

What are the potential side effects?

Deferoxamine may cause side effects such as allergic reactions in those sensitive to it. Since it's being used before potential kidney damage occurs during surgery, other specific side effects will be monitored closely due to its role in removing iron from the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for heart surgery that involves bypass or valve replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a fever of 38°C or higher in the last 48 hours.

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My kidney function is very low or I am on dialysis.

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I have or might have a serious bacterial infection in my blood, heart, or kidneys.

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I have severe hearing loss.

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I am not in a study that could interfere with deferoxamine treatment.

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My surgery will be done while my blood circulation is temporarily stopped.

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I have acute kidney injury.

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I have received kidney replacement therapy in the last week.

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I have a permanent heart pump device, not including Impella or balloon pumps.

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I am currently on a heart-lung machine support.

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I have a condition causing too much iron in my blood or have had treatment to remove excess iron.

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I am currently taking prochlorperazine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Kidney Injury

Secondary study objectives

Atrial Fibrillation

Hospital-free days

ICU-free days

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeferoxamineExperimental Treatment1 Intervention

Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours

Group II: PlaceboPlacebo Group1 Intervention

Normal saline (240mL) intravenous infusion over 12 hours

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deferoxamine

2019

Completed Phase 4

~680

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Kidney Injury (AKI) include iron chelation, fluid management, and renal replacement therapy. Iron chelation, such as with Deferoxamine, works by binding free iron in the bloodstream, which reduces oxidative stress and prevents further kidney damage. This is particularly important in AKI patients undergoing cardiac surgery, where hemolysis can release large amounts of free iron. Effective fluid management helps maintain adequate blood flow to the kidneys, preventing further injury. Renal replacement therapy, such as dialysis, supports kidney function by removing waste products and excess fluids from the blood. These treatments are crucial for stabilizing kidney function, reducing complications, and improving patient outcomes.