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Digoxin Antibodies

DigiFab for Preventing Kidney Injury After Heart Surgery

Phase 4
Recruiting
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

Study Summary

This trial is testing whether DigiFab, a medication that lowers ouabain levels, can reduce the risk of kidney damage after heart surgery.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Renal function
Secondary outcome measures
Need for dialysis

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DigifabActive Control1 Intervention
Digifab intravenous
Group II: PlaceboPlacebo Group1 Intervention
saline intravenous

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,406 Total Patients Enrolled
4 Trials studying Acute Kidney Injury
308 Patients Enrolled for Acute Kidney Injury
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 Injury Research Study Groups: Digifab, Placebo
Acute Kidney Injury 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Stephen Gottlieb 2019. "Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03810417.
All > Digoxin
~4 spots leftby Jun 2024
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