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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 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

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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,385 Total Patients Enrolled
Stephen S GottliebPrincipal InvestigatorUniversity of Maryland
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Digoxin Antibodies Fab Fragments (Digoxin Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03810417 — Phase 4
Acute Kidney Failure Research Study Groups: Digifab, Placebo
Acute Kidney Failure Clinical Trial 2023: Digoxin Antibodies Fab Fragments Highlights & Side Effects. Trial Name: NCT03810417 — Phase 4
Digoxin Antibodies Fab Fragments (Digoxin Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03810417 — Phase 4
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