General — TransplantLyfe

General

Ibox scoring system - more options for us to keep our organs alive in the future?

KarinExpert
Transplant Patient
July 30, 2025 in General

We are excited to announce that the FDA has decided to review the ibox scoring system as a potential endpoint in the transplant drug approval process. This would introduce long term outcomes and not just focus on the first year graft survival! The hope is for more drugs to enter the market, and for us patients, to have more options to keep our precious organs alive!

https://www.prnewswire.com/news-releases/transplant-therapeutics-consortium-receives-fda-notice-of-reviewability-for-the-ibox-scoring-system-full-qualification-package-302513489.html

1 - 2 of 2 Replies

  • lescp3Care Partner

    This is exciting news... and can be hard to understand! I am always learning... The term "endpoints" is newer to me. There is a 2024 webinar discussing endpoints last year where I learned a lot. "Endpoints in Clinical Trials with Dr. Newell" Reposting the link here if anyone wants to dig deeper:


    August 1, 2025
  • KarinExpert
    Transplant Patient

    An endpoint is a metric that governs the approval process.

    For example, in a weightloss study, weight might be the endpoint.

    In a diabetes study, HbA1c or average blood sugar might be an endpoint.

    In kidney transplantation, the number of kidneys still functioning at one year after surgery has been the endpoint. For years that number has been over 95 percent. We are looking for ”endpoints” that evaluate more longterm survival of the kidney and quality of life.

    August 1, 2025
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