DigiFab for Preventing Kidney Injury After Heart Surgery

No longer recruiting at 1 trial location

Overseen By Stephen Gottlieb, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Disqualifiers: Allergy to Digifab, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if DigiFab (digoxin antibodies Fab fragments) can prevent kidney damage after heart surgery. Patients undergoing procedures like coronary artery bypass grafts sometimes experience serious kidney problems. The study examines whether DigiFab can reduce levels of ouabain, a substance potentially linked to these kidney issues. Participants will receive either DigiFab or a placebo, depending on their ouabain levels. This trial targets individuals undergoing coronary artery bypass surgery who have diabetes or specific kidney function levels. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Digoxin Antibodies Fab Fragments?

Research has shown that DigiFab, the treatment being tested, is generally safe for patients. In studies using DigiFab, it shortened the duration of harmful effects from digoxin toxicity, indicating its likely safety. However, patients with kidney or heart problems should exercise caution. Some studies have shown that using DigiFab before surgery might reduce the risk of kidney injury after heart surgery. While more research is needed, current evidence suggests that DigiFab can be used safely under appropriate conditions. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Digoxin Antibodies Fab Fragments, known as DigiFab, to prevent kidney injury after heart surgery. Unlike standard treatments that primarily manage symptoms after kidney damage occurs, DigiFab works by directly neutralizing digoxin and other related compounds that might contribute to kidney injury. This approach targets the underlying cause of potential kidney damage, offering a proactive rather than reactive solution. By specifically binding to and neutralizing harmful substances, DigiFab could significantly reduce the risk of kidney injury, potentially leading to better outcomes for patients undergoing heart surgery.

What evidence suggests that DigiFab could be an effective treatment for preventing kidney injury after heart surgery?

Research has shown that DigiFab, one of the treatments studied in this trial, is designed to lower high levels of ouabain in the blood, potentially preventing kidney damage after heart surgery. High ouabain levels are linked to an increased risk of kidney injury, which can lead to dialysis and raise the risk of death. DigiFab reduces these harmful levels. Previous studies demonstrated that DigiFab can effectively lower ouabain levels, possibly reducing the risk of kidney injury in heart surgery patients. Although more research is needed, DigiFab has already proven effective for conditions like digoxin toxicity and shows promise for kidney protection. Participants in this trial may receive either DigiFab or a placebo to evaluate its effectiveness in this context. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephen S Gottlieb

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for patients who are about to have coronary artery bypass surgery and either have diabetes or a glomerular filtration rate (GFR) less than 60, but above 15. It's not for those allergic to Digifab, recently exposed to contrast dye, or with creatinine levels more than 25% above their baseline.

Inclusion Criteria

I have diabetes or my kidney function is reduced.

I am scheduled for heart bypass surgery.

My kidney function is above the minimum level required.

Exclusion Criteria

You are allergic to Digifab.

Your kidney function is more than 25% worse than it was before.

You have had contrast dye within the past 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive DigiFab or placebo intravenously before undergoing CABG surgery

1 day

Post-operative Follow-up

Participants are monitored for acute kidney injury and renal function for 72 hours after CABG surgery

72 hours

Extended Follow-up

Participants are monitored for the need for dialysis within 30 days of surgery

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Digoxin Antibodies Fab Fragments
• Placebo

Trial Overview The study is testing if DigiFab can lower ouabain levels in the blood and help prevent kidney damage after heart surgery. Participants will be randomly given either DigiFab or a placebo before their operation.

How Is the Trial Designed?

Group I: Digifab, EO > 360 Active Control 2 Interventions

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

Group II: Digifab, EO < 360 Active Control 2 Interventions

Digifab in subject with baseline ouabain concentration \< 360 pm

Group III: Placebo, EO > 360 Placebo Group 2 Interventions

saline intravenous n subject with baseline ouabain concentration \> 360 pm

Group IV: Placebo, EO < 360 Placebo Group 2 Interventions

Subjects who received Placebo in n subject with baseline ouabain concentration \< 360 pm

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study of 717 adults treated with Digoxin Immune Fab (Ovine) for digitalis intoxication, 50% of patients showed a complete response to the treatment, indicating its effectiveness in managing severe digoxin toxicity.

The treatment was generally well tolerated, with only 0.8% of patients experiencing allergic reactions and 2.8% developing recrudescent toxicity, particularly when less than 50% of the estimated antibody dose was administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digoxin Immune Fab therapy in the management of digitalis intoxication: safety and efficacy results of an observational surveillance study. Hickey, AR., Wenger, TL., Carpenter, VP., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03810417?cond=Ouabain&viewType=Table&rank=1

Preop Digifab in CABG to Reduce Ouabain Levels and ... This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery.

2. withpower.com withpower.com/trial/phase-4-acute-kidney-injury-6-2019-fbb7d

DigiFab for Preventing Kidney Injury After Heart Surgery This trial is testing DigiFab, a medication that may lower harmful substance levels in the blood, in patients undergoing heart surgery who are at high risk ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/17/NCT03810417/Prot_SAP_001.pdf

Pre-operative treatment with DigiFab to prevent post- ... Incidence and outcomes of acute kidney injury after cardiac surgery using either criteria of the RIFLE classification. BMC Nephrol. 2015;16 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK556101/

Digoxin Immune Fab - StatPearls - NCBI Bookshelf Digoxin immune Fab is an antidote for digoxin toxicity, a condition typically observed in patients with atrial fibrillation and underlying heart ...

5. serb.com serb.com/news/randomized-double-blinded-study-to-commence-on-digifab-for-kidney-injury-related-to-cabg-surgery/

Randomized double-blinded study to commence on ... This study examines whether providing DigiFab® will reduce ouabain levels and lower the risk of developing kidney damage after heart surgery.

6. link.springer.com link.springer.com/article/10.1007/s40801-024-00435-0

Characterizing Utilization and Outcomes of Digoxin ... DIF therapy appears to be beneficial in limiting duration of toxicity and intensive care unit lengths of stay in digoxin toxic patients.

7. conferences.medicom-publishers.com conferences.medicom-publishers.com/specialisation/cardiology/acc-2025/digifab-may-decrease-kidney-injury-in-high-risk-cardiac-surgery-patients/

Digifab may decrease kidney injury in high-risk cardiac ... Pre-operative treatment with digoxin immune Fab (Digifab) was associated with reduced post-operative acute kidney injury (AKI) in patients ...