Acute Kidney InjuryPhase 2DEFEAT-AKINCT04633889
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
A Phase 2 study testing Deferoxamine and Normal saline in people with Acute Kidney Injury, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Deferoxamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Apr 2021to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Deferoxamine, Normal saline
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferoxamineDrug
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
Normal salineDrug
Normal saline (240mL) intravenous infusion over 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Deferoxamine | Experimental | Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours Receives: Drug: Deferoxamine |
| Placebo | Placebo comparator | Normal saline (240mL) intravenous infusion over 12 hours Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Composite outcome that includes any of the following:
- Urine output <0.5 ml/kg/h for ≥6 consecutive hours within the first 48h or until the Foley catheter is removed, whichever occurs first
- Increase in serum creatinine ≥0.3 mg/dl within the first 48h
- Increase in serum creatinine ≥50% within 7 days
- Receipt of renal replacement therapy within 7 days
Measured: 7 days
Secondary outcomes (10)
Renal Tubular Injury
Urine KIM-1 standardized to urine creatinine
Measured: 3 days
Number of Participants With Major Adverse Kidney Events
Defined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
Measured: 7 days
Number of Participants With Postoperative Myocardial Injury
Defined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
Measured: 2 days
Number of Participants With Atrial Fibrillation or Atrial Flutter
Defined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
Measured: 7 days
Number of Participants With Prolonged Mechanical Ventilation
Defined as a requirement for mechanical ventilation >24h postoperatively
Measured: 24 hours
Time to Liberation From Vasoactive Medications
Number of hours from time of incision to liberation from all IV vasoactive medications
Measured: 7 days
Number of Participants With Sepsis
Defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is defined as an acute increase in the total SOFA score ≥2 points consequent to the infection.
Measured: 7 days
Ventilator-free Days
28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
Measured: 28 days
ICU-free Days
28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.
Measured: 28 days
Hospital-free Days
28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start13 Apr 2021
- Primary completion26 Aug 2024
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, David Leaf, Brigham and Women's Hospital
- Investigators
- David E. Leaf, MD, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633889
- Sponsor's protocol ID
- 2020P003605
- Other IDs
- R01DK125786
- Acronym
- DEFEAT-AKI
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma S, Leaf DE. Iron Chelation as a Potential Therapeutic Strategy for AKI Prevention. J Am Soc Nephrol. 2019 Nov;30(11):2060-2071. doi: 10.1681/ASN.2019060595. Epub 2019 Sep 25.
PubMed 31554656Scurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1.
PubMed 38689404
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04633889
- Acronym / sponsor ID
- DEFEAT-AKI / 2020P003605
- Conditions
- Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferoxamine | Experimental | Drug: DeferoxamineDeferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours |
| Placebo | Placebo comparator | Drug: Normal salineNormal saline (240mL) intravenous infusion over 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- AKI, defined as any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeferoxamineDeferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours | Drug | Deferoxamine |
| Normal salineNormal saline (240mL) intravenous infusion over 12 hours | Drug | Placebo |
Primary outcome
Acute Kidney Injury
Time frame: 7 days
Composite outcome that includes any of the following: 1. Urine output <0.5 ml/kg/h for ≥6 consecutive hours within the first 48h or until the Foley catheter is removed, whichever occurs first 2. Increase in serum creatinine ≥0.3 mg/dl within the first 48h 3. Increase in serum creatinine ≥50% within 7 days 4. Receipt of renal replacement therapy within 7 days
10 secondary outcomes
Renal Tubular Injury
Time frame: 3 days
Number of Participants With Major Adverse Kidney Events
Time frame: 7 days
Number of Participants With Postoperative Myocardial Injury
Time frame: 2 days
Number of Participants With Atrial Fibrillation or Atrial Flutter
Time frame: 7 days
Number of Participants With Prolonged Mechanical Ventilation
Time frame: 24 hours
Time to Liberation From Vasoactive Medications
Time frame: 7 days
Number of Participants With Sepsis
Time frame: 7 days
Ventilator-free Days
Time frame: 28 days
ICU-free Days
Time frame: 28 days
Hospital-free Days
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31554656Sharma S, Leaf DE. Iron Chelation as a Potential Therapeutic Strategy for AKI Prevention. J Am Soc Nephrol. 2019 Nov;30(11):2060-2071. doi: 10.1681/ASN.2019060595. Epub 2019 Sep 25.
- Derived from this study: PubMed 38689404Scurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E. Leaf, MD, MMSc principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferoxamine and Normal saline in people with Acute Kidney Injury, run by Brigham and Women's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633889, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.