Trial Outcomes & Findings for Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury (NCT NCT04633889)
NCT ID: NCT04633889
Last Updated: 2026-06-12
Results Overview
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
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
320 participants
Primary outcome timeframe
7 days
Results posted on
2026-06-12
Participant Flow
The discrepancy between the number of patients enrolled (n=320) versus the number randomized, dosed, and included in the final analysis (n=301) was due to some patients being withdrawn from the study after enrollment but prior to randomization.
Participant milestones
| Measure |
Deferoxamine
Deferoxamine 30mg/kg IV infusion x 12 hours starting preoperatively; Maximum total dose, 6g
|
Placebo
Saline IV infusion x 12 hours starting preoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
150
|
|
Overall Study
COMPLETED
|
151
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg IV infusion x 12 hours starting preoperatively; Maximum total dose, 6g
|
Placebo
n=150 Participants
Saline IV infusion x 12 hours starting preoperatively
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Age, Continuous
|
69 years
n=9 Participants
|
70 years
n=27 Participants
|
70 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=9 Participants
|
36 Participants
n=27 Participants
|
81 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=9 Participants
|
114 Participants
n=27 Participants
|
220 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=9 Participants
|
139 Participants
n=27 Participants
|
273 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=9 Participants
|
140 Participants
n=27 Participants
|
283 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 7 daysComposite 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
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Acute Kidney Injury
|
99 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: The number of patients analyzed varies across rows due to differences in sample availability. Samples were not collected in certain cases, including when patients did not produce urine, declined sample collection, or when study staff were otherwise unable to obtain the specimen.
Urine KIM-1 standardized to urine creatinine
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Renal Tubular Injury
Postoperative Day 1
|
3.37 ng/mg
Interval 1.64 to 6.18
|
3.61 ng/mg
Interval 2.0 to 6.27
|
|
Renal Tubular Injury
Postoperative Day 2
|
4.34 ng/mg
Interval 1.81 to 8.41
|
3.83 ng/mg
Interval 1.99 to 6.88
|
|
Renal Tubular Injury
Preoperative
|
1.24 ng/mg
Interval 0.68 to 2.21
|
1.48 ng/mg
Interval 0.82 to 2.65
|
|
Renal Tubular Injury
End of Cardiopulmonary Bypass
|
2.64 ng/mg
Interval 1.53 to 5.33
|
2.37 ng/mg
Interval 1.22 to 5.46
|
|
Renal Tubular Injury
ICU Arrival
|
1.61 ng/mg
Interval 0.98 to 3.02
|
1.91 ng/mg
Interval 0.8 to 3.35
|
SECONDARY outcome
Timeframe: 7 daysDefined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Number of Participants With Major Adverse Kidney Events
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 2 daysDefined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Number of Participants With Postoperative Myocardial Injury
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 7 daysDefined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
Outcome measures
| Measure |
Deferoxamine
n=102 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=90 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation or Atrial Flutter
|
33 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 24 hoursDefined as a requirement for mechanical ventilation \>24h postoperatively
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Number of Participants With Prolonged Mechanical Ventilation
|
31 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 7 daysNumber of hours from time of incision to liberation from all IV vasoactive medications
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Time to Liberation From Vasoactive Medications
|
29 Hours
Interval 20.0 to 59.0
|
30 Hours
Interval 15.0 to 50.0
|
SECONDARY outcome
Timeframe: 7 daysDefined 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.
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Number of Participants With Sepsis
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 28 days28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Ventilator-free Days
|
27 Days
Interval 27.0 to 28.0
|
28 Days
Interval 27.0 to 28.0
|
SECONDARY outcome
Timeframe: 28 days28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
ICU-free Days
|
25 Days
Interval 23.0 to 26.0
|
25 Days
Interval 23.0 to 26.0
|
SECONDARY outcome
Timeframe: 28 days28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.
Outcome measures
| Measure |
Deferoxamine
n=151 Participants
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 Participants
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Hospital-free Days
|
20 Days
Interval 16.0 to 22.0
|
20 Days
Interval 14.0 to 22.0
|
Adverse Events
Deferoxamine
Serious events: 23 serious events
Other events: 0 other events
Deaths: 6 deaths
Placebo
Serious events: 25 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Deferoxamine
n=151 participants at risk
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
|
Placebo
n=150 participants at risk
Normal saline (240mL) intravenous infusion over 12 hours
|
|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/151 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
0.00%
0/150 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
2.0%
3/151 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
0.67%
1/150 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
|
Infections and infestations
Infection/Sepsis
|
7.9%
12/151 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
5.3%
8/150 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
|
Cardiac disorders
Vasoactive-Inotropic Score ≥30
|
11.3%
17/151 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
14.0%
21/150 • All-cause mortality was measured from initiation of the study drug until discharge from the index hospital admission during which the study drug was administered, up to 1 year; Vasoactive-Inotropic Score (VIS) was measured for 24-hours following study drug initiation; anaphylaxis was measured throughout the 12 hour study drug administration period; Infection/Sepsis and ARDS were measured for 7 days following the study drug administration.
We limited the scope of our adverse events (AEs) monitoring and reporting to a prespecified list of AEs of special interest (AESI)-anaphylaxis, infection/sepsis, VIS ≥ 30, and ARDS-since the patient population was undergoing high risk surgery and it was expected that they would have a number of unrelated adverse health events during the course of their hospital stay.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place