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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
End Stage Renal Disease 18 yrs or older
Negative serum pregnancy unless surgically sterile or post menopausal for >1yr
Must not have
Documented requirement for >5,000 units of Heparin per catheter lumen to maintain catheter patency (with decrease in blood flow demonstrated at 5,000 units per lumen Heparin catheter lock) with current catheter
Contraindications to citrate or taking drugs that may interact with citrate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Approved for 20 Other Conditions
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My catheter needs more than 5,000 units of Heparin to stay open.
Select...
I am not allergic to citrate and am not on medications that interact with it.
Select...
I have not had any active bleeding or a positive test for blood in my stool in the last 28 days.
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I have redness or pus around my catheter site larger than a small coin.
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I have a history of G6PD deficiency or drug-induced methemoglobinemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your most recent lab tests show that you don't have low calcium or low platelet count.My catheter needs more than 5,000 units of Heparin to stay open.My doctor thinks I might need cardiovascular care for up to 6 months.I am not allergic to citrate and am not on medications that interact with it.You do not have any signs of blood infection in the three dialysis sessions before the start of the study.Your average blood pressure during the last three dialysis treatments is higher than 90 mmHg.I have not had any active bleeding or a positive test for blood in my stool in the last 28 days.I haven't taken antibiotics for infections in the last 14 days, or Vancomycin in the last 30 days.You have a known allergy to sodium citrate, methylene blue, methyl/paraben, or propyl paraben.I have redness or pus around my catheter site larger than a small coin.The amount of liquid needed to fill the catheter tubes is not known.I am 18 or older with advanced kidney failure.I need chemotherapy or radiation within the next 6 months.I have a history of G6PD deficiency or drug-induced methemoglobinemia.Your blood test must show no signs of infection before you can join the study.I am not pregnant, have had surgery to prevent pregnancy, or have been menopausal for over a year.You are allergic to Heparin or have had a specific type of reaction to it in the past.My dialysis flow rate has been over 300 mL/min recently.You have a long-term blood clotting problem shown by consistently high Prothrombin or Partial Thromboplastin Time, or very low platelet count.This criterion is describing the different types of dialysis catheters, including single-body catheters with different configurations and a twin catheter with two separate functions.Your Kt/V or URR levels are above a certain number.
Research Study Groups:
This trial has the following groups:- Group 1: Heparin
- Group 2: AAT-023 (Zuragen Arm)
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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