11:00 AM EDT Participating Clinical Centers (PCC): Status Updates - PowerPoint PPT Presentation

ZEDS Coordinators Conference Call April 24, 2019 11:00 AM EDT

Participating Clinical Centers (PCC): Status Updates Centers “Green Lighted” for Screening and Randomization  N=66  54 Centers with Patient Activity  08 Centers with No Patient Activity  04 Center Inactive/Closed Study Participants Screened  N=192 2

Participating Clinical Centers (PCC): Status Updates Study Participants Randomized!! 3

4

Data Management  TrialMaster  Enter data into TrialMaster, 3-5 days after patient visit  When data is not readily available and a form is left in the IMCOMPLETE status, please go back and complete within 3-5 days  Query responses are due also 3-5 days after they have been created  eGFR >45 How to handle it. 5

eGFR  If the study participant had a baseline eGFR of 45-59 repeat eGFRs will be completed prior to the 3, 6, 9 month study visits.  If eGFR is 45 or above, study medication will be continued.  If eGFR is less than 45, the study medication will be discontinued, and the eGFR will be repeated within one week. If on repeat testing the eGFR:  is 45 or more, the study medication will be resumed, and eGFR will be repeated within 30 days of the next study visit.  is less than 45, study participant will be given a prescription to visit their local study designated laboratory for monthly eGFR testing until it is 45 or more. In addition, study participants will be told to see their primary care doctor for management of their kidney disease. The study medication will not be resumed, and the study participant will continue to be followed in the study. 6

New Satellites Locations at PCCs  PCCs that have more than one location can have a separate inventory of study medication at all locations  Must have staff available (investigator and coordinator)  Study participants expected to have all study visits (when study medication is dispensed) to be completed at that location  Satellite locations will have a separate center number, beginning with 501  No new contract or IRB approval required  All payments will go to “parent” location 7

New PCC Payments  Coordinator effort for pre-screening activities  Pay $10 per chart entered onto screening log  Screening log revised to capture date patient was pre-screened and referral source  Six month trial  Began on March 15, 2019  PCCs notified March 11, 2019  REMINDER: Send in your screening logs the first week of the month 8

Revised Screening Log 9

New PCC Payments  Coordinator professional development  Reimbursement for a coordinator from top two PCCs to attend the AAO annual meeting  PCCs to be announced in June  Participant stipend  $20 per completed visit with data entered  Status: Approved by CIRB and sent to PCCs with local IRB oversight for submission  Referral letters and script for potential study participants have also been revised. 10

Primary Endpoint Training module  NEW Primary Endpoint Training module sent out 01/25/2019  Training to be completed by ALL investigators  Deadline: 02/15/2019  Training log is verification that training is complete  Coordinators should review the slides and have available as a reference  NEW Verification Form for Possible Primary Endpoint  Investigator verifies the data submitted are complete and accurate  Separate form for each diagnosis of new/worsening DEK, SK, EK IR or SKU 11

12

Updates and Reminders  New Batch of Study Medication Expiring in 2021  Medication started arriving at PCCs  System will not allow the batch expiring April 2019 to be dispensed  We will begin the process of disposal in May 2019  MOP  Protocol 2.0 revisions have been incorporated  Posted on the ZEDS website 13

14