What is the mechanism of action of this treatment?

The most common treatments for Acute Kidney Injury (AKI) include interventions like fluid resuscitation, diuretics, and medications that target specific pathways involved in kidney damage. For instance, DigiFab works by lowering ouabain levels, a substance linked to increased risk of kidney damage, thereby potentially reducing the incidence of AKI post-surgery. Fluid resuscitation helps maintain adequate blood flow to the kidneys, preventing further injury. Diuretics can help manage fluid overload, a common complication in AKI. These treatments are crucial as they aim to preserve kidney function, prevent progression to chronic kidney disease, and reduce the need for dialysis, ultimately improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Acute Kidney Injury (AKI) include diuretics like furosemide and antibiotics like nitrofurantoin. Furosemide, used to manage fluid overload, can cause side effects such as electrolyte imbalances, dehydration, and ototoxicity. Nitrofurantoin, an antibiotic, is generally well-tolerated but can cause gastrointestinal disturbances and, rarely, pulmonary or hepatic toxicity. DigiFab, which lowers ouabain levels, is being studied for its potential to reduce AKI risk, but specific side effects related to this treatment are not well-documented yet.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly target ouabain levels to reduce the risk of acute kidney injury (AKI). Current treatments for AKI primarily focus on managing underlying causes and supportive care, such as maintaining fluid balance and avoiding nephrotoxic agents. Some investigational drugs, like QPI-1002 and human recombinant alkaline phosphatase (recAP), have been studied in clinical trials for their potential to treat AKI, but they have different mechanisms of action compared to DigiFab. Therefore, DigiFab's approach to lowering ouabain levels represents a novel strategy in the prevention of AKI.

What other types of research exist?

Promising novel alternatives to DigiFab for treating acute kidney injury in 2024 include QPI-1002, THR-184, BB-3, heme arginate, human recombinant alkaline phosphatase (recAP), ciclosporin A, AB103, and levosimendan.

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Digoxin Antibodies

DigiFab for Preventing Kidney Injury After Heart Surgery

Phase 4

Waitlist Available

Led By Stephen S Gottlieb

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of Diabetes Mellitus or GFR < 60

Undergoing coronary artery bypass surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of DigiFab may include allergic reactions, changes in electrolyte levels which could affect the heart rhythm, and other potential immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have diabetes or my kidney function is reduced.

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I am scheduled for heart bypass surgery.

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My kidney function is above the minimum level required.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Renal function

Secondary study objectives

Need for dialysis

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DigifabActive Control1 Intervention

Digifab intravenous

Group II: PlaceboPlacebo Group1 Intervention

saline intravenous

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Kidney Injury (AKI) include interventions like fluid resuscitation, diuretics, and medications that target specific pathways involved in kidney damage. For instance, DigiFab works by lowering ouabain levels, a substance linked to increased risk of kidney damage, thereby potentially reducing the incidence of AKI post-surgery. Fluid resuscitation helps maintain adequate blood flow to the kidneys, preventing further injury. Diuretics can help manage fluid overload, a common complication in AKI. These treatments are crucial as they aim to preserve kidney function, prevent progression to chronic kidney disease, and reduce the need for dialysis, ultimately improving patient outcomes.

Contrast-induced acute kidney injury in interventional cardiology: Emerging evidence and unifying mechanisms of protection by remote ischemic conditioning.