DigiFab for Preventing Kidney Injury After Heart Surgery

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

267 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 for kidney damage. By reducing these levels, DigiFab could help protect the kidneys from damage.

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.

Is DigiFab safe for use in humans?

DigiFab, also known as digoxin-specific antibody fragments, has been used safely in humans to treat digoxin poisoning. In studies, it was generally well tolerated, with only a small percentage of patients experiencing allergic reactions or other adverse effects. ^{1 2 3 4 5}

How is the drug DigiFab unique in preventing kidney injury after heart surgery?

DigiFab, a digoxin-specific antibody fragment, is unique because it binds to digoxin and similar molecules, allowing for their rapid removal from the body through the kidneys. This mechanism, originally used to treat digoxin poisoning, may help prevent kidney injury by reducing the toxic effects of digoxin-like substances on the kidneys. ^{1 5 6 7 8}

What data supports the effectiveness of the drug Digoxin Antibodies Fab Fragments for preventing kidney injury after heart surgery?

Digoxin-specific antibody fragments (digoxin-Fab) are known to be effective in treating digoxin poisoning by binding to the drug and allowing it to be safely removed from the body, which suggests they might help in managing drug-related kidney issues by reducing the active drug levels in the body. ^{1 6 9 10 11}

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.

You have had contrast dye within the past 3 days.

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

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. United States pubmed.ncbi.nlm.nih.gov

Effects of sheep digoxin-specific antibodies and their Fab fragments on digoxin pharmacokinetics in dogs. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Reversal of digitalis effects by specific antibodies. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Digoxin-specific antibody fragments in the treatment of digoxin toxicity. [2017]

4. England pubmed.ncbi.nlm.nih.gov

The plasma disposition and renal elimination of digoxin-specific Fab fragments and digoxin in the rabbit. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Influence of digoxin immune Fab therapy and renal dysfunction on the disposition of total and free digoxin. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Contrasting rates of reversal of digoxin toxicity by digoxin-specific IgG and Fab fragments. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Digoxin Immune Fab therapy in the management of digitalis intoxication: safety and efficacy results of an observational surveillance study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of life-threatening digitalis intoxication with digoxin-specific Fab antibody fragments: experience in 26 cases. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Reversal of advanced digoxin intoxication with Fab fragments of digoxin-specific antibodies. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Digoxin poisoning and anuric acute renal failure: efficiency of the treatment associating digoxin-specific antibodies (Fab) and plasma exchanges. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of non-digitalis binding properties of digoxin-specific Fabs using direct binding methods. [2017]