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Zuragen vs Heparin for Chronic Kidney Failure
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Heparin
- Group 2: AAT-023 (Zuragen Arm)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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