Trial · NCT04633889

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

NCT04633889, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2026-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury. Trials, record NCT04633889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04633889

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
NCT number: NCT04633889
Status: Completed
Phases: Phase 2
Enrollment: 320 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Acute Kidney Injury
Interventions: Deferoxamine, Normal saline
First posted: 2020-11-18
Last updated: 2026-10-06
Results first posted: 2026-01-26

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Acute Kidney Injury	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
Secondary	Renal Tubular Injury	3 days	Urine KIM-1 standardized to urine creatinine
Secondary	Number of Participants With Major Adverse Kidney Events	7 days	Defined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
Secondary	Number of Participants With Postoperative Myocardial Injury	2 days	Defined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
Secondary	Number of Participants With Atrial Fibrillation or Atrial Flutter	7 days	Defined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
Secondary	Number of Participants With Prolonged Mechanical Ventilation	24 hours	Defined as a requirement for mechanical ventilation \>24h postoperatively
Secondary	Time to Liberation From Vasoactive Medications	7 days	Number of hours from time of incision to liberation from all IV vasoactive medications
Secondary	Number of Participants With Sepsis	7 days	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.
Secondary	Ventilator-free Days	28 days	28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
Secondary	ICU-free Days	28 days	28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Acute Kidney Injury	7 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Renal Tubular Injury	3 days
SECONDARY	Number of Participants With Major Adverse Kidney Events	7 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Postoperative Myocardial Injury	2 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Atrial Fibrillation or Atrial Flutter	7 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Prolonged Mechanical Ventilation	24 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Liberation From Vasoactive Medications	7 days	Hours	MEDIAN
SECONDARY	Number of Participants With Sepsis	7 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Ventilator-free Days	28 days	Days	MEDIAN
SECONDARY	ICU-free Days	28 days	Days	MEDIAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Acute Kidney Injury	Deferoxamine	99	Participants
Acute Kidney Injury	Placebo	108	Participants
Number of Participants With Major Adverse Kidney Events	Deferoxamine	14	Participants
Number of Participants With Major Adverse Kidney Events	Placebo	13	Participants
Number of Participants With Postoperative Myocardial Injury	Deferoxamine	15	Participants
Number of Participants With Postoperative Myocardial Injury	Placebo	15	Participants
Number of Participants With Atrial Fibrillation or Atrial Flutter	Deferoxamine	33	Participants
Number of Participants With Atrial Fibrillation or Atrial Flutter	Placebo	32	Participants
Number of Participants With Prolonged Mechanical Ventilation	Deferoxamine	31	Participants
Number of Participants With Prolonged Mechanical Ventilation	Placebo	27	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Deferoxamine	151
Overall Study	STARTED	Placebo	150
Overall Study	COMPLETED	Deferoxamine	151
Overall Study	COMPLETED	Placebo	150
Overall Study	NOT COMPLETED	Deferoxamine	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Anaphylaxis	Immune system disorders	Deferoxamine	0	151
serious	Anaphylaxis	Immune system disorders	Placebo	0	150
serious	ARDS	Respiratory, thoracic and mediastinal disorders	Deferoxamine	3	151
serious	ARDS	Respiratory, thoracic and mediastinal disorders	Placebo	1	150
serious	Infection/Sepsis	Infections and infestations	Deferoxamine	12	151
serious	Infection/Sepsis	Infections and infestations	Placebo	8	150
serious	Vasoactive-Inotropic Score ≥30	Cardiac disorders	Deferoxamine	17	151
serious	Vasoactive-Inotropic Score ≥30	Cardiac disorders	Placebo	21	150

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferoxamine	6	151
Total, all-cause mortality	Placebo	6	150
Total, other adverse events	Deferoxamine	0	151
Total, other adverse events	Placebo	0	150
Total, serious adverse events	Deferoxamine	23	151
Total, serious adverse events	Placebo	25	150

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31554656	BACKGROUND	PubMed
38689404	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK125786	Deferoxamine for the Prevention of Acute Kidney Injury	LEAF, DAVID EVAN	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2020 to 2024

Source NIH RePORTER

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Deferoxamine vs Placebo: Acute Kidney Injury	Trial comparisons
Deferoxamine vs Placebo: Number of Participants With Prolonged Mechanical Ventilation	Trial comparisons
Deferoxamine vs Placebo: Number of Participants With Sepsis	Trial comparisons
Deferoxamine vs Placebo: Number of Participants With Postoperative Myocardial Injury	Trial comparisons
Deferoxamine vs Placebo: deaths from any cause	Trial comparisons
Deferoxamine vs Placebo: Number of Participants With Major Adverse Kidney Events	Trial comparisons
Deferoxamine vs Placebo: Number of Participants With Atrial Fibrillation or Atrial Flutter	Trial comparisons
Deferoxamine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04633889

GET https://conductscience.org/api/trials/v1/NCT04633889/registered

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