Acute Kidney InjuryPhase 4NCT03810417

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

A Phase 4 study testing Digoxin Antibodies Fab Fragments, Baseline EO > 360 pM and EO < 360 pM in people with Acute Kidney Injury, run by University of Maryland, Baltimore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury
What is being tested?: Digoxin Antibodies Fab Fragments, Baseline EO > 360 pM and EO < 360 pM
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 267 participants
Where: 2 sitesUnited States
Study dates: 22 Jul 2019to 30 Apr 2024
Phase: Phase 4
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

Undergoing coronary artery bypass surgery
glomerular filtration rate > 15 History of Diabetes Mellitus or GFR < 60

Who cannot join

Allergy to Digifab Contrast dye within 3 days Creatinine > 25% above baseline

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland
Baltimore, Maryland, 21201
St Josephs Medical Center
Baltimore, Maryland, 21204

Other trials in United States

About this study

Official title: Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery

Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.

Read the detailed description

This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a follow up period of 72 hours post CABG surgery.

Conditions: Acute Kidney Injury
Being tested: Digoxin Antibodies Fab Fragments, Placebo, Baseline EO > 360 pM, EO < 360 pM
Keywords: coronary artery bypass surgery, ouabain, acute kidney injury
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.

Digoxin Antibodies Fab FragmentsDrug
Digoxin antibodies
PlaceboOther
Saline
Baseline EO > 360 pMDiagnostic test
Baseline ouabain concentration > 360 pM
EO < 360 pMDiagnostic test
Baseline ouabain concentration < 360 pM

Study groups in NCT03810417
Study group	Role	What they receive
Digifab, EO > 360	Active comparator	Digifab intravenous in subject with baseline ouabain concentration > 360 pm Receives: Drug: Digoxin Antibodies Fab Fragments; Diagnostic Test: Baseline EO > 360 pM
Placebo, EO > 360	Placebo comparator	saline intravenous n subject with baseline ouabain concentration > 360 pm Receives: Other: Placebo; Diagnostic Test: Baseline EO > 360 pM
Digifab, EO < 360	Active comparator	Digifab in subject with baseline ouabain concentration < 360 pm Receives: Drug: Digoxin Antibodies Fab Fragments; Diagnostic Test: EO < 360 pM
Placebo, EO < 360	Placebo comparator	Subjects who received Placebo in n subject with baseline ouabain concentration < 360 pm Receives: Other: Placebo; Diagnostic Test: EO < 360 pM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

AKI
Development of AKI at 72 hours
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201930 Apr 2024

First posted18 Jan 2019
Study start22 Jul 2019
Primary completion30 Apr 2024
Study completion30 Apr 2024

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.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients undergoing coronary artery bypass surgery
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03810417
Sponsor's protocol ID: HP-00083553
Status last verified: Sep 2026
First submitted: 8 Jan 2019
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery
ClinicalTrials.gov ID: NCT03810417
Acronym / sponsor ID: HP-00083553
Conditions: Acute Kidney Injury
Keywords: coronary artery bypass surgery, ouabain, acute kidney injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 22 Jul 2019 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 30 Apr 2024 (actual)
First posted: 18 Jan 2019 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Patients undergoing coronary artery bypass surgery

Arm	Type	Receives
Digifab, EO > 360	Active comparator	Drug: Digoxin Antibodies Fab Fragments, Diagnostic Test: Baseline EO > 360 pMDigifab intravenous in subject with baseline ouabain concentration > 360 pm
Placebo, EO > 360	Placebo comparator	Other: Placebo, Diagnostic Test: Baseline EO > 360 pMsaline intravenous n subject with baseline ouabain concentration > 360 pm
Digifab, EO < 360	Active comparator	Drug: Digoxin Antibodies Fab Fragments, Diagnostic Test: EO < 360 pMDigifab in subject with baseline ouabain concentration < 360 pm
Placebo, EO < 360	Placebo comparator	Other: Placebo, Diagnostic Test: EO < 360 pMSubjects who received Placebo in n subject with baseline ouabain concentration < 360 pm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Undergoing coronary artery bypass surgery
glomerular filtration rate > 15 History of Diabetes Mellitus or GFR < 60

Key exclusion criteria (1 listed)

Allergy to Digifab Contrast dye within 3 days Creatinine > 25% above baseline

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
Digoxin Antibodies Fab FragmentsDigoxin antibodies	Drug	Digifab, EO < 360, Digifab, EO > 360
PlaceboSaline	Other	Placebo, EO < 360, Placebo, EO > 360
Baseline EO > 360 pMBaseline ouabain concentration > 360 pM	Diagnostic test	Digifab, EO > 360, Placebo, EO > 360
EO < 360 pMBaseline ouabain concentration < 360 pM	Diagnostic test	Digifab, EO < 360, Placebo, EO < 360

Primary outcome

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

1 secondary outcome

AKI
Time frame: 3 days

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Digifab Below Median	70	66
Placebo Below Median	64	59
Digifab Above Median	64	59
Placebo Above Median	69	66

Primary outcome: Renal Function

Time frame: 72 hours. Median (Inter-Quartile Range). Unit: mL/min/1.73m^2

Measure	Digifab, EO > 360 n = 59	Placebo, EO > 360 n = 66	Digifab, Eo < 360 n = 66	Placebo, EO < 360 n = 59
Value	.46 (-7.4 to 7.5)	.75 (-9.1 to 6.2)	4.26 (-0.89 to 11.59)	2.80 (-4.07 to 13.17)

Digifab, EO > 360 vs Placebo, EO > 360: p >0.05, Regression, Linear
Digifab, EO > 360 vs Placebo, EO > 360: p <0.05, Regression, Logistic

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digifab and EO > 360 pM	17 of 59 (28.8%)	0 of 59 (0%)	0 of 59
Placebo, EO > 360 p	20 of 66 (30.3%)	0 of 66 (0%)	2 of 66
Digifab and EO < 360 pM	14 of 66 (21.2%)	0 of 66 (0%)	1 of 66
Placebo, EO < 360 pM	16 of 59 (27.1%)	0 of 59 (0%)	2 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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Recruiting
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Recruiting
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Not yet recruitingObservational study
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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.

Stephen S Gottlieb principal investigator

University of Maryland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 1 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 7 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 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Jul 2025). 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?

Renal Function (time frame: 72 hours). 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 NCT03810417.

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 7 Oct 2026.