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Device

Zuragen vs Heparin for Chronic Kidney Failure

Phase 3
Waitlist Available
Research Sponsored by Ash Access Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expectation by Investigator that CVCD may be needed for up to 26 weeks
End Stage Renal Disease 18 yrs or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare the effects of AAT-023 to those of Heparin in preventing Catheter Related Blood Stream Infections in patients with End Stage Renal Disease.

Who is the study for?
Adults with End Stage Renal Disease who need a chronic central venous catheter for dialysis and can maintain it for up to 26 weeks. Participants must have stable blood pressure, no current infections, and not be pregnant or breastfeeding. Excluded are those with heparin allergies, active bleeding, certain co-morbidities like HIV or recent transplants, and those on conflicting medications.Check my eligibility
What is being tested?
The study is testing if AAT-023 (Zuragen) solution is better than Heparin at preventing bloodstream infections in patients using tunneled dialysis catheters. Patients will be randomly assigned to receive either Zuragen or Heparin as part of their treatment regimen.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the solutions' components such as sodium citrate or parabens in Zuragen. There's also a risk of bleeding complications with Heparin use especially in individuals with clotting disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor thinks I might need cardiovascular care for up to 6 months.
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I am 18 or older with advanced kidney failure.
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I am not pregnant, have had surgery to prevent pregnancy, or have been menopausal for over a year.
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My dialysis flow rate has been over 300 mL/min recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To show that AAT-023 (Zuragen) solution is superior to Heparin in preventing CRBSI when used as a catheter lock solution in CVCD's between hemodialysis treatments.
Secondary outcome measures
To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AAT-023 (Zuragen Arm)Experimental Treatment1 Intervention
Active experimental consisting of AAT-023 (Zuragen)solution
Group II: HeparinActive Control1 Intervention
5000 units diluted with normal saline to the exact catheter lumen volume

Find a Location

Who is running the clinical trial?

Ash Access TechnologyLead Sponsor

Media Library

AAT-023 solution (Zuragen) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT00628680 — Phase 3
Kidney Failure Research Study Groups: Heparin, AAT-023 (Zuragen Arm)
Kidney Failure Clinical Trial 2023: AAT-023 solution (Zuragen) Highlights & Side Effects. Trial Name: NCT00628680 — Phase 3
AAT-023 solution (Zuragen) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00628680 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it federally legal to use AAT-023 solution (Zuragen)?

"AAT-023 solution (Zuragen) has been rated a 3 for safety by our team at Power. This is because Zuragen is in Phase 3 trials, which means that there is both some efficacy data and multiple rounds of safety data."

Answered by AI

Are there any other completed or ongoing studies that are similar to this one involving AAT-023 solution (Zuragen)?

"AAT-023 solution (Zuragen) was first studied at Bayview Nephrology, Inc. in 2006. As of now, there have been 190 completed clinical trials with 45 active studies. Ocala, Florida has a high concentration of these active studies."

Answered by AI

Are patients being enrolled in this experiment as we speak?

"Unfortunately, this study is not recruiting patients at the moment. It was initially posted on July 1st, 2006 but the most recent update was on March 4th, 2008. However, there are presently 769 other clinical trials actively recruiting participants with pyemia and 45 trials for AAT-023 solution (Zuragen) that are looking for patients."

Answered by AI

Will this clinical trial be the first of its kind?

"AAT-023 solution (Zuragen) has had a long research history, with the first study being sponsored by Ash Access Technology in 2006. After the successful initial study of 415 patients, AAT-023 solution (Zuragen) received Phase 3 drug approval. As of now, there are 45 active trials for AAT-023 solution (Zuragen) being conducted in 211 cities and 23 countries."

Answered by AI

What is AAT-023 solution (Zuragen) used to treat patients for?

"Zuragen (AAT-023) can not only be used to clean and disinfect medical devices, but also to treat common conditions such as atrial fibrillation, sprains, and unstable angina pectoris."

Answered by AI

How many research sites are participating in this project?

"At the moment, there are 22 sites where this trial is enrolling patients. If you are considering enrolling, know that there are locations in Ocala, Spring Hill, and Hudson. Additionally, it might be helpful to choose a location close to you to limit travel."

Answered by AI

How many volunteers are participating in this trial?

"Unfortunately, this study is not currently looking for new patients to enroll. Although, it is worth noting that the trial was most recently updated on March 4th, 2008. If you are interested in other studies, there are 769 clinical trials for pyemia and 45 for AAT-023 solution (Zuragen) that are actively admitting patients."

Answered by AI
~22 spots leftby Mar 2025