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AAT-023 Clinical Trial Update
Issue 4, February 9, 2007

New Site Updates

The following sites have been qualified and will be initiated this month:

  • Dr. Herman in Buffalo, NY
  • Dr. Koeper in Appleton, WI
  • Dr. Cheriyan in Fairfax, VA
  • Dr. Matalon in New York, NY
  • Dr. Brown in Boston, MA

Fun Stuff!

Congratulations to Allie Salvi, one of the Averion monitors, on her engagement! She and her fiancé, are planning an October wedding. Best wishes, Allie & Pete!!

Tip of the Month
Your monitor needs to review original source documentation. Please be sure to provide access to ALL dialysis charts, medical records, etc.


Save the Date!

Coordinator Meeting February 23-24, 2007
Swan and Dolphin Hotel The meeting will take place at the Walt Disney World Dolphin Hotel.

We have a had a great response to our upcoming coordinator meeting! We look forward to an informative and interactive day. Some of the planned agenda items include discussions with some of your fellow coordinators. They will be discussing successful recruiting and screening practices, and logistical issues (i.e., keeping your dialysis staff involved to get the data needed for the study, device storage/accountability).

We’ll also be reviewing study assessments, inclusion/exclusion criteria, adverse device effects, unanticipated adverse device effects; CRBSI and Patency Failure evaluations. See you in Orlando!


CRF TIPS

COMPLETION OF SCREENING BLOOD FLOW HISTORY CRF (Page 1)

  • BFR dates should be from the three most recent hemodialysis treatments prior to ran¬domization.
  • Record the average BFR from each treatment.
  • Do not use the randomization treatment date.

*******

Please Note: If your site received any damaged Case Report Form binders they can be replaced by StatKing. Please contact Carolyn Buck or Marla Hoelle at (513) 858-2989.

Remember!
In order to meet inclusion criteria, you should be making sure that the average of the 3 BFRs are over 300 ml/mm and systolic BPs are > 90 mmHG at the start of the 3 most recent dialysis sessions just PRIOR to randomization.


Enrollment Progress As of 2/9/07
Dr. Hariachar, Hudson, FL (101)
26
Dr. Posner, Baltimore, MD (103)
5
Dr. Rogers, Ocala, FL (104)
13
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
15
Dr. Al-Makki, Lafayette, IN (107)
5
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
34
Dr. Fadem, Houston, TX (110)
1
Dr. Roer, Waterbury, CT (111)
12
Dr. Kapatkin, Brandon, FL (112)
1
Dr. Halligan, Erie, PA (113)
0
Dr. Abbott, Orlando, FL (114)
0
Dr. Cheriyan, Fairfax, VA (115)
0
Total Randomized
118

Medical Monitor Phone Number: (765) 413-7676
All questions regarding Inclusion/Exclusion criteria compliance, potential adverse device effects, patient safety, and other medical issues related to the study should be referred to the Medical Monitor.

 

From the Sponsor

It seems as soon as January, 2007 arrived, it was over already! Not only did the new year bring new hopes and new resolutions, it has brought many new team members to the AZEPTIC (Analysis of Zuragen’s Efficacy in Preventing & Treating Infection in Catheters) Trial for ZuragenTM. We are grateful for all of you who have been with us since we launched the study last year, and we are equally grateful for each new teammate who has joined us along the way.

This is indeed a vitally important study for the health and quality of life for hemodialysis patients (and other potential patient populations in the future) who use catheters for their vascular access. The frequency and impact of the complications (infections and thrombosis) these patients face due to their vascular access are staggering. Your work to complete the pivotal ZuragenTM clinical work will potentially bring treatment change that could be felt around the world.

We are excited about this mission and know that many of you are as well. Our supporters are many – the NIH has committed $2.7 million to help fund our study. The State of Indiana has committed $2 million through is 21st Century Fund. Many investors and leading thought leaders in the medical community also believe in the world-changing potential of the ZuragenTM. Inquiries about this product and the AZEPTIC study continue to grow...we truly are pioneering a new path for a significant unmet medical need!

We now have 18 sites approved for our study. Our goal is to have 20 sites approved, initiated and enrolling patients by the end of the month. We need your continued commitment to complete enrollment by June, 2007. Should each site meet the attainable enrollment goals we have set forth, this can be done. We trust you have seen that we will provide you with the resources and tools you need to fulfill the challenge and we look forward to hearing and sharing your successes in the weeks ahead at the AZEPTIC Study Coordinator Meeting.

Thank you, again. Your commitment and hard work are making a difference!

Since you are reading this page, you are already aware of the Clinical Trial page on this website. Make sure you notice that the Clinical Trial page contains all issues of the study newsletter, a PDF of the trial poster and local newsletter example, site contact information, Q&A log, and CRF re-order form. Please contact Averion or Ash if you think of any useful additions to the website, or have any feedback!