Endpoints and Trial Designs to Advance Development in Kidney Transplantation

Dear AAKP Ambassadors, Friends, and Allies:

Over the past year, AAKP has highlighted the unmet needs of transplant patients and transplant professionals and the long-overdue need for innovations to transcend status quo immunosuppressive drugs. These drugs were developed over 20 or 40 years ago based on an endpoint of 1-year graft survival, with no substantive consideration of drug side effects like nephrotoxicity or long-term transplant patient outcomes.

On November 9th from 8:00 a.m. - 4:30 p.m. ET, the U.S. Food and Drug Administration (FDA) is hosting a Public Workshop titled “Endpoints and Trial Designs to Advance Development in Kidney Transplantation.” This is a hybrid event, so we strongly encourage all Ambassadors and Allies to register to join virtually. You can learn more about the workshop, view the agenda, and register by clicking here.

We need you to attend, listen, and ask the FDA panelists questions during the discussion period on what the agency plans are for approving a new endpoint and accelerating the next generation of transplant drugs.

The November 9th event represents the fifth public meeting in eight years by the FDA regarding transplant drug innovation and unmet patient needs. The last meeting was conducted in 2018. AAKP Ambassador Kevin Fowler wrote a superb article about the hopes FDA created 5 years ago – you can read that article here.

The kidney patient community fully rejects the idea of maintaining the status quo in transplant drugs – because it is not good for patients or the future of transplantation. Take a look at the highlights of what more than 1,200 kidney patients and living donors said in a recent AAKP survey on this issue. The implications of new drugs are profound for increasing living donation and transplantation. (View Survey)

In 2018, the FDA tasked the transplant community and industry to create a new endpoint through the FDA-backed Critical Path Institute and the Transplant Therapeutics Consortium (TTC). After 5 years of great effort – involving FDA advisors, patients, top researchers, industry, and transplant surgeons - TTC submitted an application to the FDA for approval of a new, proposed clinical endpoint to the FDA on July 31, 2023.

AAKP fully endorsed the TTC application submitted to the FDA. Earlier today, over 50 AAKP patients and care partners, from 31 states, conducted over 100 meetings with Congressional leaders to tell them about the unmet needs of transplant patients, the side effects of status quo medicines, and the lack of outcomes measured beyond 1-year graft survival. We encouraged Congressional leaders to closely monitor the FDA’s decision on the TTC application and how the FDA responds to the patient insights and lived experiences they have heard for the past decade.

The kidney community elevated transplantation as the preferred therapy for kidney failure over dialysis during the past decade. We also made it a consensus American priority under multiple Congresses as well as under Presidents Barack Obama, Donald Trump, and Joe Biden.

During this Decade of the Kidney™, you can help make certain future immunosuppressive drugs reflect the latest in science and innovation to extend life. Absent your voice, there is a strong possibility that old technologies and the outdated mindset of “good enough” will continue to shape the lives and livelihoods of America’s transplant recipients.

We look forward to ‘seeing’ you at the workshop!

Diana Clynes

Executive Director, AAKP