Expanded Access Policy

  • ProKidney is developing rilparencel for patients with Chronic Kidney Disease (CKD).
  • Consistent with our commitment to bring innovative, safe, and effective therapies to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our therapies available as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access these investigational therapies. We encourage patients interested in our investigational therapies to learn more about our ongoing studies by visiting clinicaltrials.gov.
  • “Expanded Access” refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious or life-threatening condition.
  • In the event ProKidney decides to consider making one or more of its investigational therapy products available to patients who have a serious or life-threatening condition through an Expanded Access Protocol, the following criteria must be met:
    • The patient has a serious or immediately life-threatening condition.
    • There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
    • Patient enrollment in a clinical trial is not possible.
    • Potential patient benefit justifies the potential risks of treatment.
    • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
  • All requests would be evaluated on a case-by-case basis in a fair and equitable manner and in accordance with FDA regulations.
  • Treating physicians may request additional information about ProKidney’s Expanded Access policy by contacting our clinical team:
    • By email at eap@prokidney.com
    • ProKidney will acknowledge receipt of the inquiry within 5 business days from receipt.
  • This policy shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.
  • ProKidney reviews its policies from time to time to ensure conformity with applicable laws and regulations. We reserve the right to revise this policy at any time.