Trial Outcomes & Findings for Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury (NCT NCT04633889)
NCT ID: NCT04633889
Last Updated: 2026-05-04
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
2026-05-04
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(n=320) versus the number randomized, dosed, and included in the final analysis (n=301) was due to some patients being withdrawn from the study after enrollment but prior to randomization.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
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=54 Participants
|
70 years
n=60 Participants
|
70 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=54 Participants
|
36 Participants
n=60 Participants
|
81 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=54 Participants
|
114 Participants
n=60 Participants
|
220 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
17 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=54 Participants
|
139 Participants
n=60 Participants
|
273 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
17 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=54 Participants
|
140 Participants
n=60 Participants
|
283 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 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 daysUrine levels of KIM-1
Outcome measures
Outcome data not reported
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