Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

NCT03810417 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HP-00083553
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Kidney Injury

Keywords

coronary artery bypass surgery; ouabain; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• AKI

  3 days

Study Arms (4)

Digifab, EO > 360

ACTIVE COMPARATOR

Digifab intravenous in subject with baseline ouabain concentration \> 360 pm

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

Other: Placebo; Diagnostic Test: Baseline EO > 360 pM

Digifab, EO < 360

ACTIVE COMPARATOR

Digifab in subject with baseline ouabain concentration \< 360 pm

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

Other: Placebo; Diagnostic Test: EO < 360 pM

Interventions

Digoxin Antibodies Fab Fragments DRUG

Digoxin antibodies

Digifab, EO < 360; Digifab, EO > 360

Placebo OTHER

Saline

Placebo, EO < 360; Placebo, EO > 360

Baseline EO > 360 pM DIAGNOSTIC_TEST

Baseline ouabain concentration \> 360 pM

Digifab, EO > 360; Placebo, EO > 360

EO < 360 pM DIAGNOSTIC_TEST

Baseline ouabain concentration \< 360 pM

Digifab, EO < 360; Placebo, EO < 360

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

St Josephs Medical Center

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

digoxin antibodies Fab fragments

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Stephen Gottlieb, MD
• Organization: University of Maryland

sgottlie@som.umaryland.edu

410-328-7877

Study Officials

• Stephen S Gottlieb

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational pharmacy will provide active drug or placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Patients undergoing coronary artery bypass surgery

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 18, 2019
• Study Start: July 22, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)