Trial Outcomes & Findings for Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI (NCT NCT03810417)

NCT ID: NCT03810417

Last Updated: 2025-07-02

Results Overview

Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 267 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2025-07-02

Participant Flow

Patients randomized and double blinded

Participant milestones

Measure	Digifab Below Median Received Digifab with baseline ouabain below 360 pm	Placebo Below Median Received placebo with baseline ouabain below 360 pm	Digifab Above Median Digifab intravenous with baseline ouabain above 360 pm	Placebo Above Median saline intravenous with baseline ouabain above 360 pm
Overall Study STARTED	70	64	64	69
Overall Study COMPLETED	66	59	59	66
Overall Study NOT COMPLETED	4	5	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements

Baseline characteristics by cohort

Measure	Digifab Below Median n=70 Participants Received Digifab with baseline ouabain below median	Placebo Below Median n=64 Participants Received placebo with baseline ouabain below median	Digifab Above Median n=64 Participants Digifab intravenous with baseline ouabain above median	Placebo Above Median n=69 Participants saline intravenous with baseline ouabain above median	Total n=267 Participants Total of all reporting groups
Age, Continuous	66 years n=66 Participants • Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements	67 years n=59 Participants • Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements	65 years n=59 Participants • Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements	70 years n=66 Participants • Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements	67 years n=250 Participants • Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements
Sex: Female, Male Female	15 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	14 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	15 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	16 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	60 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Sex: Female, Male Male	51 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	45 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	44 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	50 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	190 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) Asian	1 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	4 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	1 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	2 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	8 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) Black or African American	9 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	16 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	9 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	5 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	39 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) White	54 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	39 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	49 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	59 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	201 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) More than one race	1 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	1 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=59 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	0 Participants n=66 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.	1 Participants n=250 Participants • Only patients who received study drug and had surgery were analyzed, as per the protocol.

PRIMARY outcome

Timeframe: 72 hours

Population: Randomized study with endpoint assessed in those with baseline ouabain concentration (EO) above and below 360 pM

Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours

Outcome measures

Measure	Digifab, EO > 360 n=59 Participants Received Digifab and had a baseline EO concentration \> 360	Placebo, EO > 360 n=66 Participants Received placebo and had a baseline EO concentration \> 360	Digifab, Eo < 360 n=66 Participants Subjects who received digifab and had baseline ouabain \< 360	Placebo, EO < 360 n=59 Participants Subjects who received placebo and had a baseline ouabain \< 360
Renal Function	.46 mL/min/1.73m^2 Interval -7.4 to 7.5	.75 mL/min/1.73m^2 Interval -9.1 to 6.2	4.26 mL/min/1.73m^2 Interval -0.89 to 11.59	2.80 mL/min/1.73m^2 Interval -4.07 to 13.17

SECONDARY outcome

Timeframe: 3 days

Population: Results by intervention and baseline ouabain concentration

Development of AKI at 72 hours

Outcome measures

Measure	Digifab, EO > 360 n=59 Participants Received Digifab and had a baseline EO concentration \> 360	Placebo, EO > 360 n=66 Participants Received placebo and had a baseline EO concentration \> 360	Digifab, Eo < 360 n=66 Participants Subjects who received digifab and had baseline ouabain \< 360	Placebo, EO < 360 n=59 Participants Subjects who received placebo and had a baseline ouabain \< 360
AKI	5 participants	12 participants	8 participants	8 participants

Adverse Events

Digifab and EO > 360 pM

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, EO > 360 p

Serious events: 20 serious events

Other events: 0 other events

Deaths: 2 deaths

Digifab and EO < 360 pM

Serious events: 14 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo, EO < 360 pM

Serious events: 16 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Digifab and EO > 360 pM n=59 participants at risk Received Digifab and baseline ouabain concentration \> 360 pM	Placebo, EO > 360 p n=66 participants at risk Received placebo and baseline ouabain concentration \> 360 pM	Digifab and EO < 360 pM n=66 participants at risk Received Digifab and baseline ouabain concentration \< 360 pM	Placebo, EO < 360 pM n=59 participants at risk Received placebo and baseline ouabain concentration\< 360 pM
Cardiac disorders Diverse	28.8% 17/59 • Number of events 30 • 30 days	30.3% 20/66 • Number of events 39 • 30 days	21.2% 14/66 • Number of events 27 • 30 days	27.1% 16/59 • Number of events 31 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Stephen Gottlieb, MD

University of Maryland

Phone: 410-328-7877

Email: sgottlie@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place