Guidance on End of Treatment 

As we progress through the study, please remember that participants who do not complete all procedures should continue their study participation. This helps us capture important safety and efficacy data. Additionally, participants reaching transplant, dialysis, or specific kidney function milestones have abbreviated follow-up schedules. If you have any questions, please contact your PSI CRA or Medical Monitor.  

End of Treatment (EOT) 

• Occurs when a participant receives either: 

• Two rilparencel/sham injections (standard completion), OR 

• One rilparencel/sham injection if they discontinued treatment early 

• It does NOT mean the end of study participation 

• If they don’t complete all procedures, encourage continued participation through Global Trial End Date (GTED) and transition to an abbreviated schedule (do not automatically withdraw).  

Reasons End of Treatment in EDC: 

• Withdrawal by subject – participant is unable or unwilling to complete the treatment portion of the study (biopsy/sham or injection/sham)  

• Pregnancy 

• Withdrawal of consent – participant decides to stop his/her participation in the study and revokes consent.  

• If this option is selected, End of Study form should also be completed. 

• Physician Decision – If the decision is related to an adverse event, select Adverse Event instead. 

• Adverse event – discontinuation due to any adverse event must be reflected in the AE form with ‘dose withdrawn’ selected as the action taken.   

• Death  

• Non-compliance with study schedule 

• Sponsor Request – If the request is related to an adverse event, select Adverse Event instead. 

• Lost to Follow-Up – the participant fails to return to the clinic for their scheduled visit and does not respond to attempts to contact. 

• Protocol Deviation – Examples include, but are not limited to, randomization errors and/or enrollment of participants who do not meet eligibility criteria.  

• Request for termination by sponsor or investigator – This option is no longer expected to be selected as a reason for termination.   

• Physician Decision or Sponsor Request should be used in its place, as appropriate.  

• Other, specify (free text) 

• Note: If treatment is discontinued due to eGFR <15 and this is not clinically significant or reported as an AE, enter the following in the Other, specify field: “Discontinued for criteria eGFR <15 ml/min/1.73m2.” 

End of Study (EOS) 

• Conducted at GTED or at time of early withdrawal 

• MRI waived if completed within prior 6 months 

• Should include all assessments in Schedule of Events when possible