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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
DEFEAT-AKI Trial Summary
This trial will test whether prophylactic administration of a deferoxamine decreases the incidence of acute kidney injury (AKI) following cardiac surgery.
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.Check my eligibility
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.See study design
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.
DEFEAT-AKI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for heart surgery that involves bypass or valve replacement.
DEFEAT-AKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Kidney Injury
Secondary outcome measures
Atrial Fibrillation
Hospital-free days
ICU-free days
+8 moreDEFEAT-AKI 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
~630
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,034 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
449 Patients Enrolled for Acute Kidney Injury
Brigham and Women's HospitalLead Sponsor
1,611 Previous Clinical Trials
11,470,219 Total Patients Enrolled
7 Trials studying Acute Kidney Injury
1,702 Patients Enrolled for Acute Kidney Injury
Massachusetts General HospitalOTHER
2,929 Previous Clinical Trials
13,198,005 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
104,274 Patients Enrolled for Acute Kidney Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your urine output is less than half a milliliter per kilogram of body weight per hour for six hours in a row, and you are being monitored every hour with a Foley catheter.Your kidney function has significantly worsened in the past week, or if there's no recent test, then the most recent test in the last 3 months shows a significant change.I have had a fever of 38°C or higher in the last 48 hours.Your blood creatinine levels have increased by at least 0.3 mg/dl in the past 48 hours.My kidney function is very low or I am on dialysis.I've had pneumonia or lung infection shown in a chest scan in the last week.I have or might have a serious bacterial infection in my blood, heart, or kidneys.I have severe hearing loss.I am not in a study that could interfere with deferoxamine treatment.I am 18 years old or older.I am scheduled for heart surgery that involves bypass or valve replacement.My surgery will be done while my blood circulation is temporarily stopped.You are allergic to deferoxamine.I have acute kidney injury.I have received kidney replacement therapy in the last week.You tested positive for COVID-19 in the last 10 days.I have a permanent heart pump device, not including Impella or balloon pumps.I am currently on a heart-lung machine support.Your risk for acute kidney injury is high, with a score of 6 or more at the time of screening.Your hemoglobin level is less than 8 grams per deciliter in the past 3 months.I have a condition causing too much iron in my blood or have had treatment to remove excess iron.I am currently taking prochlorperazine.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Deferoxamine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential harms exist with the administration of Deferoxamine?
"Our in-house assessment of Deferoxamine's safety is a 2, as it has been tested and observed to be safe with no evidence that the drug can effectively treat any condition."
Answered by AI
How many participants have enrolled in this research project?
"True. The clinicaltrial.gov website indicates that the study, which was initiated on April 13th 2021, is still actively recruiting patients for participation. Across 3 distinct sites, this trial needs to register 300 individuals in order to be completed."
Answered by AI
What conditions can Deferoxamine be utilized to address?
"Deferoxamine is the primary therapy to reduce iron accumulation, but it may also be beneficial in treating aluminium overload, chronic kidney failure and other related concerns."
Answered by AI
Are there any open slots available for enrollment in this research study?
"Data posted on clinicaltrials.gov states that this medical trial is actively searching for individuals to enrol in the program, which was initially published on April 13th 2021 and last modified November 21st 2022."
Answered by AI
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