Test protocol to increase kidney usage approved

Published on: Tuesday, July 23, 2024

The OPTN Executive Committee, at a meeting June 24, approved the first protocol to be tested among a planned series of intended approaches to increase organ usage through more efficient placement. The revised variance process supports the work of the OPTN Expeditious Task Force, which is applying and assessing ways to increase usage of donated organs.

The protocol, to begin testing in August, will allow placement earlier in the organ offer process of deceased donor kidneys with a Kidney Donor Profile Index (KDPI) of 75 percent or higher. The KDPI value reflects the likely length of kidney function (graft survival) as compared to all deceased kidney donors; a higher value indicates the kidney will be less likely to function as long as a kidney from a lower-KDPI donor. (See a video that explains the KDPI score and how it is used in kidney allocation.) Kidneys from donors with a KDPI of 70 percent or higher are considerably less likely to be transplanted than kidneys from donors with lower KDPI values.

The trial will include up to five organ procurement organizations (OPOs). The OPOs will be selected from different areas of the country and will have different levels of volume with KDPI 75-100 percent kidneys being recovered, transplanted, or not used. In turn, the selected OPOs will identify kidney transplant programs who are likely to receive organ offers from them and have experience or interest in using high-KDPI kidneys.

When a participating OPO recovers kidneys from donors in this KDPI range, it will first offer those kidneys to high priority candidate classifications in OPTN policy. After that, but before other candidates in the policy sequence, the OPO would make offers to candidates that the participating kidney programs have pre-identified as being willing and eligible to receive such offers.

The goal of the trial is to determine whether more kidneys from high-KDPI donors can be used successfully by identifying appropriate candidates and prioritizing them at an early stage of the placement process. Transplant activity and outcomes will be closely monitored throughout the trial period; outcomes will be studied both for whether it meets intended goals and whether it may have unintended results. Additional details about the protocol, including plans for monitoring, are available here [link to detailed proposal document when available].

Additional protocols will be developed for trial and assessment using updates to the OPTN variance process recently approved by the OPTN Board of Directors. Any interested person or organization may review the details of the protocol and offer input, which will be posted on the OPTN website and considered along with evaluation of the protocol’s results.

Multiple protocols can be developed and tested simultaneously in short-term, time-limited trials. Any approaches that show positive results and could be used in OPTN policy will be referred to the appropriate OPTN committee(s) for consideration through the policy development process.