Kidney Transplantation Committee Update John J. Friedewald, MD Committee Chair Meetings

 Progress to develop a new national kidney allocation system  Recommendations regarding variances  Kidney Paired Donation Ongoing Projects

NATIONAL KIDNEY ALLOCATION SYSTEM

 Simulation modeling completed and results reviewed by Committee  Objectives for a new system were met (limitations of current system addressed)  Committee voted to send out a policy proposal in the fall Progress Update

Top 20 % KDPI to Top 20 % EPTS Allocation under “current rules” (All Candidates) Opt in system of highest 15% KDPI kidneys “Think improved ECD” Patients rank ordered by Waiting /ESRD time DR matching Sliding scale CPRA System features A2 -> B Broader sharing CPRA>=98% Patients rank ordered by Waiting/ESRD time System features Regional sharing A2 -> B Broader sharing CPRA>=98% Current Working Model KDPI Scale

Addressing System Limitations Stated Limitation of the Current SystemApplicable Concepts Mismatch between potential survival of the kidney and the recipient Longevity matching Variability in access to transplantation by blood group and geographic location A2/A2B, broader sharing High discard rates of kidneys that could benefit candidates on the waiting list KDPI, expedited placement Reduce differences in transplant access for populations described in NOTA (e.g., candidates from racial/ethnic minority groups, pediatric candidates, and sensitized candidates). ESRD time, broader sharing, CPRA sliding scale, maintain peds priority

SIMULATION MODELING RESULTS

Summary Table Average for 10 iterationsN1N4 Number of candidates (on waitlist at start or joining during run) 122,669 Average number of primary transplant recipients (KI+KP) 11,531 (11, ,586) 11,365 (11, ,409) Average median lifespan post-transplant (min, max of runs) ( ) ( ) Average median graft years of life (min, max of runs) 8.82 ( ) 9.10 ( ) Average median extra life-years for tx recipient versus waitlist candidate (min, max of runs) 5.01 ( ) 5.27 ( ) Average median LYFT per transplant (min, max of runs) 5.70 ( ) 5.97 ( )

Kidney Transplants by Recipient Blood Type

Kidney Transplants by Recipient Age To Table

Kidney Transplants by Recipient Race

Kidney Transplants by 0 HLA mismatches

Kidney Transplants by Organ Sharing

Kidney Transplants by Recipient CPRA, with waitlist prevalence To Table

N3 versus N4 N3N4 Local CPRA Regional CPRA National CPRA first priority for all kidneys Local CPRA 100 Regional CPRA 100 National CPRA 100 Local CPRA 99 Regional CPRA 99 Local CPRA 98 first priority for all kidneys

Kidney Transplants by Recipient cPRA, To Table

Kidney Transplants by Recipient CPRA To Table

Projected median patient years of life per transplant: average, minimum, maximum of runs

Projected median graft years per transplant: average, minimum, maximum of runs

Projected LYFT per transplant: average, minimum, maximum of runs

VARIANCE REVIEW PROCESS

Variances The Committee received rationales from the above OPOs wishing to keep existing variances in the new allocation system PADV PATF TXSB TXGC OKOP VATB Reg 1

 Discontinuation of all variances except for  Dialysis waiting time study  A 2 /A 2 B  Align changes to take place at the time a new kidney allocation system is implemented  Allow applications for transition  Recommendations will be circulated for public comment in the fall Variance Recommendations

Estimated DateAction June 25, 2012 OPTN/UNOS Board of Directors reviews recommendations for discontinuation (no action at this time) Fall 2012 Public Comment for new national kidney allocation system and transition plans approved by the Committee June 2013 Board of Directors considers proposal and transition plans Fall 2013Approved transition plans implemented TBD (likely 2014)New kidney allocation system implemented and transition plans ended Timeline for KAS and Variance Proposals

Kidney Paired Donation Pilot Program Update

Overall Match Run Results Match Run DateCandidatesDonors Candidates Matched Candidates Transplanted November 15, December 12, January 25, February 23, March 21, April 4, April 19, scheduled May 2, May 16, pending June 12, pending June 19, pending TOTAL19, 16 pending

 Centers refusing matches based on combinations of low-level antibodies  Donor Pre-Select Tool  Frequency of match runs  Now running matches twice a month  Will increase frequency as resources allow but ultimate flexibility depends on automation of the match run Barriers and Potential Solutions

 Sizes of exchanges  Testing a smaller exchange size (chain cap of 4) in June match runs Barriers and Potential Solutions

June 12, 2012 Match Run Results (#22) Participants included in the match 154 candidates (88 highly sensitized) 170 total donors 5 NDDs (2 A, 1 AB, 2 B) 48 centers from 11 regions had at least one eligible pair Results 16 matched candidates (including waiting list candidates) One 4-chain exchange, Two 3-chain exchanges, Two 3-ways 6 candidates have a CPRA>= 80% 3 NDDs who matched (1A, 2B)

KPD Work Group Activities

 Two proposals completing public comment:  KPD Policy to replace Operational Guidelines  Comments focused on histocompatibility section and whether the program is ready for policy language  Bridge Donor Proposal  Public comment supportive of including bridge donors  Both proposals likely to be forwarded to the Board in November 2012 KPD Policy

KPD Automated Solution Update

 Released on December 12, 2011  Included the ability to:  Enter KPD application from UNet℠  Add and maintain donors and candidates  Search for donors and candidates  Verify ABO  Print records Pre-Match Data Entry Screens

 Released on May 24, 2012:  Allows users to view whether candidates and donors are eligible for the next match run in real time  Includes warning messages for potential data entry errors Eligibility Processing

 “I really like the app and think it's user interface should set the standard for other programs. It's a great first step.”  “The addition of eligibility status to the UNet KPD module is a HUGE benefit! I love it that it now tells what is still missing, so we don't have to go hunting for it. Will try to get some more pairs ready for next week's match run. " Feedback from Users

 Donor pre-select tool  Automation of the match run  Display of match results  Tracking of match responses Future Functionality

Questions?

BACKUP SLIDES

Counts of Kidney Transplants by Recipient CPRA CPRA Group Run0vs N1 1-19vs N vs N vs N vs N vs N1 95+vs N N N N Back To Figure

Counts of Kidney Transplants by Recipient CPRA, 95+ CPRA Group Run95 vs N1 96vs N197 vs N1 98 vs N1 99 vs N1 100 vs N1 N N N N Back To Figure

Counts of Kidney Transplants, by Recipient Age Age Group Run<18 vs N vs N vs N vs N1 65+ vs N1 N N N N Back To Figure

Sharing by cPRA 98+

Sharing by 0mm

Pediatric and Adult Transplants by Sharing

Adult and Pediatric Transplants by Top 20/Bottom 80

Top 20 recipients by HLA-mismatch

Sharing by run N2 projects a similar amount of sharing as N1 N3 projects fewer local transplants than N1

Sharing by run, continued N4 projects fewer local transplants than N1 N4 projects more local transplants than N3