ZEDS Coordinators Conference Call April 24, 201911:00 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

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Participating Clinical Centers (PCC): Status Updates

Study Participants

Randomized!!

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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.

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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.

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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

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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

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Revised Screening Log

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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.

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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

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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

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