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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digifab, EO > 360 | Active Comparator | Digifab intravenous in subject with baseline ouabain concentration > 360 pm |
|
| Placebo, EO > 360 | Placebo Comparator | saline intravenous n subject with baseline ouabain concentration > 360 pm |
|
| Digifab, EO < 360 | Active Comparator | Digifab in subject with baseline ouabain concentration < 360 pm |
|
| Placebo, EO < 360 | Placebo Comparator | Subjects who received Placebo in n subject with baseline ouabain concentration < 360 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin Antibodies Fab Fragments | Drug | Digoxin antibodies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function | Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AKI | Development of AKI at 72 hours | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen S Gottlieb | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States | ||
| St Josephs Medical Center |
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Patients randomized and double blinded
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| ID | Title | Description |
|---|---|---|
| FG000 | Digifab Below Median | Received Digifab with baseline ouabain below 360 pm |
| FG001 | Placebo Below Median | Received placebo with baseline ouabain below 360 pm |
| FG002 | Digifab Above Median | Digifab intravenous with baseline ouabain above 360 pm |
| FG003 | Placebo Above Median | saline intravenous with baseline ouabain above 360 pm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As per the protocol, The only patients analyzed are those who received study drug,and had surgery. Therefore 250 patients were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Digifab Below Median | Received Digifab with baseline ouabain below median |
| BG001 | Placebo Below Median | Received placebo with baseline ouabain below median |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Agre (years) | Only patients who received study drug and had surgery were analyzed. 17 patients randomized did not fulfil these requirements |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Renal Function | Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours | Randomized study with endpoint assessed in those with baseline ouabain concentration (EO) above and below 360 pM | Posted | Median | Inter-Quartile Range | mL/min/1.73m^2 | 72 hours |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digifab and EO > 360 pM | Received Digifab and baseline ouabain concentration > 360 pM |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverse | Cardiac disorders | Systematic Assessment | Secondary to surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Gottlieb, MD | University of Maryland | 410-328-7877 | sgottlie@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2022 | Jun 7, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C050199 | digoxin antibodies Fab fragments |
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Patients undergoing coronary artery bypass surgery
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Investigational pharmacy will provide active drug or placebo
| Placebo | Other | Saline |
|
| Baseline EO > 360 pM | Diagnostic Test | Baseline ouabain concentration > 360 pM |
|
| EO < 360 pM | Diagnostic Test | Baseline ouabain concentration < 360 pM |
|
| Baltimore |
| Maryland |
| 21204 |
| United States |
| BG002 | Digifab Above Median | Digifab intravenous with baseline ouabain above median |
| BG003 | Placebo Above Median | saline intravenous with baseline ouabain above median |
| BG004 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Only patients who received study drug and had surgery were analyzed, as per the protocol. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Only patients who received study drug and had surgery were analyzed, as per the protocol. | Count of Participants | Participants | No |
|
| Digifab, Eo < 360 |
Subjects who received digifab and had baseline ouabain < 360 |
| OG003 | Placebo, EO < 360 | Subjects who received placebo and had a baseline ouabain < 360 |
|
|
|
| Secondary | AKI | Development of AKI at 72 hours | Results by intervention and baseline ouabain concentration | Posted | Number | participants | 3 days |
|
|
|
| 0 |
| 59 |
| 17 |
| 59 |
| 0 |
| 59 |
| EG001 | Placebo, EO > 360 p | Received placebo and baseline ouabain concentration > 360 pM | 2 | 66 | 20 | 66 | 0 | 66 |
| EG002 | Digifab and EO < 360 pM | Received Digifab and baseline ouabain concentration < 360 pM | 1 | 66 | 14 | 66 | 0 | 66 |
| EG003 | Placebo, EO < 360 pM | Received placebo and baseline ouabain concentration< 360 pM | 2 | 59 | 16 | 59 | 0 | 59 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|