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Azeptic Trial Update
Issue 7, June 15, 2007

Happy Summer

Tip of the Month
Worksheet Completion


When to complete the worksheets?

  • Patency Failure: IF the patient's BFR goes below the patency threshold AND at least one, but not more than three interventions are performed AND the BFR does NOT go above the established threshold. Fax a copy of the worksheet to the Blinded Evaluator.
  • CRBSI: IF the patient has a suspected CRBSI and a blood sample is drawn from BOTH the catheter and peripheral vein OR catheter and exit site sample. Fax a copy of the lab results along with the worksheet to the Blinded Evaluator.

CRF TIPS

Hints & Tips to Avoid Queries

  • Please do NOT use abbreviations on Medical & Surgical History, Physical Exam or Concomitant Medications pages (i.e. you will need to spell out ‘hypertension’ vs. HTN). This helps to eliminate a lot of guesswork on the part of the Data Entry team.
  • You need to record AT LEAST the YEAR for start/stop dates for Medical & Surgical History, Physical Exam or Concomitant Medications. UNK/UNK/UNK is NOT acceptable to the FDA!!!
  • Documentation for amount of catheter lock used: if the patient is randomized to ZuragenTM (AAT-023), please record the total amount of ZuragenTM required to fill the catheter lumens plus .3 overfill. If randomized to heparin, please record the 5000 u of heparin PLUS the amount of normal saline used to the fill volume of the catheter lumens. BOTH NEED TO BE RECORDED IN YOUR SOURCE DOCUMENTS (i.e. dialysis flow sheets, progress notes, etc.) as well!

PLEASE be sure to discuss the AZEPTIC trial with your dialysis staff and provide appropriate guidance to assure the protocol is being followed. If additional in-service trainings are needed, please contact Rita, Allie, or your monitor.

New Site Updates

Enrollment Progress As of 6/11/07
Please remember to send in your enrollment log each Friday
Dr. Hariachar, Hudson, FL (101)
33
Dr. Stephanz, (102)
0
Dr. Fadem, Houston, TX (103)
7
Dr. Rogers, Ocala, FL (104)
19
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
24
Dr. Al-Makki, Lafayette, IN (107)
13
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
39
Dr. Posner, Baltimore, MD (110)
3
Dr. Roer, Waterbury, CT (111)
30
Dr. Kapatkin, Brandon, FL (112)
5
Dr. Halligan, Erie, PA (113)
12
Dr. Abbott, Orlando, FL (114)
16
Dr. Cheriyan, Fairfax, VA (115)
1
Dr. Koeper, Appleton, WI (116)
5
Dr. Herman, Buffalo, NY (117)
14
Dr. Matalon, New York, NY (118)
13
Dr. Williamson (119)
2
Dr. Shetye (121)
0
Dr. Cooper (122)
0
Total Randomized
242

Fun Stuff!

Flag Day was first observed in 1877 on the 100th anniversary of the Continental Congress' adoption of the Stars and Stripes as the official flag of the United States. In that year, Congress asked that all public buildings fly the flag on June 14. The idea quickly caught on and many people wanted to participate in waving the flag. One early supporter was B. J. Cigrand, a Wisconsin schoolteacher who wanted June 14 to be known as "Flag Birthday." In 1916, President Woodrow Wilson proclaimed Flag Day as a national celebration. However, the holiday was not officially recognized until 1949 when President Harry Truman signed the National Flag Day Bill.


Helpful Tips from StatKing

  1. Queries will be sent to study sites on Thursdays for arrival to your site on Friday. The queries will be sent out every other week. The most recent set of queries were sent out on June 14, 2007.
  2. Please remember to check if a medical history captured on the Baseline Medical History Form is resolved or ongoing.
  3. Don’t forget to check the frequency and intensity of a sign/symptom if yes is checked for a sign or symptom experienced during dialysis on CRF pages 11-13 Baseline— Common Symptoms Experienced during Hemodialysis.
  4. If you answered no to the question of CRF page 17.__ Hemodialysis Treatment Form— Part I “Patency Failure?” You do not need to answer the question “If yes, was the patency failure confirmed by Central Blinded Evaluator.?”
  5. If a protocol exception is granted, please make sure to record the name of the medical monitor contacted under the “Medical Monitor Contact” on CRF page 6.

Remember!

The AVERAGE of the most recent three Blood Flow Rates just prior to randomization must be over 300. For example, if a patient was randomized on 6/11/07, and the three previous treatments had an average BFR of 265, 340 and 315, the average of the three is 306 and the patient would be eligible for the study.

Please be sure to re-screen any patients who may have been affected by this clarification.

If you have any questions, please contact Rita or Allie at Averion.

 

From the Sponsor

Happy Summer!!! We hope you are looking forward to warmer weather, longer days, upcoming vacation plans and of course, completing enrollment in the AZEPTIC Trial for ZuragenTM. We have made some nice progress in patient enrollment since the Study Coordinator meeting in Orlando at the end of February. In the 3 month timeframe since, we have enrolled an additional 120 patients and have approached the 250 patient benchmark. In addition, we have worked with the FDA to add 4 new study sites which will bring our total of sites participating in the trial to 22.

While we have much to celebrate, we still have quite a bit of work to do over the next few months to meet our enrollment objective of 400 patients at some point this summer. We are really counting on all of you to thoroughly screen and randomize “new” catheter patients entering your units or “re-screen” patients who may have screen failed as a result of antibiotic use, positive cultures or poor blood flows. We are confident you can make this happen!

As you will recall from the SC Meeting, we rolled out our latest “educational” incentive program for those sites meeting or exceeding their enrollment target by June 15, 2007. We have moved that date back to June 30 after personally visiting all of the sites and hearing your feedback. We are very pleased to announce that several study sites will certainly hit their “target”. Stay tuned for next month’s newsletter as we announce and highlight those particular study sites.

Finally, we want to thank you again for all of the efforts you continue to put forth. We are well aware of the time commitment and dedication that is required for successful execution of our trial. We hope that you still share our enthusiasm for the pioneering research we are all participating in and realize the significant unmet medical need we are working to address. We have tremendous confidence that if this trial is successful in meeting the primary / secondary endpoints, ZuragenTM could have significant application and potential to improve the patient care and outcomes associated with the use of vascular access devices across a variety of healthcare settings. Please don’t hesitate to contact us or any member of the clinical trial team if you have any additional comments or questions.

Best Regards,

Ash Access Technology, Inc Team

 


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.

 

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 Access if you think of any useful additions to the website, or have any feedback!