General
Ibox scoring system - more options for us to keep our organs alive in the future?
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!
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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:
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.
so i wonder with the "end points" can you then evaluate longer than just a year of function what does it look like after 5 years or 10 years? i am excited to see the i-box scoring system start to work and look at new "end points" thanks karin for sharing this in the community
Transplant Patient
Yes! @Berriosa1234 that is exactly the goal - if you add parameters such as GFR etc, the totality of those would allow for projections into the future…
This is so great!!