STEP
NKG Copenhagen 18/11 2015
L Wennberg
Background
Scandiatransplant ≈ 25 x106
2014: 1212 Rtx (352 LD RTx)
Background
• NKG 11-2013
– Kidney Paired Exchange Program within the Nordic
countries
• All countries except Finland (their law only allow LDtx between
Next of Kin) was willing to investigate further into the possible
amount of LD at each center
• NKG ad-hoc meeting, 4-2014
– Evaluating the need, interest and possibilities for a kidney
exchange program in Scandinavia
• NKG 11-2015
– The basic principles in Scandia Transplant Kidney Exchange
Program (STEP) were presented
– STEP will probably (hopefully) be activated and tested
during 2015. The first match runs will be done in a local
database, however as soon as possible it will be integrated
and be a part of the Scandiatransplant database.
STEP
(”Scandia Transplant kidney Exchange Program”)
Working group (Swedish Pilot Study)
• Professor Tommy Andersson, Lunds Universitet, Lund
• Docent Per Lindner, Docent Lars Mjörnstedt, Sahlgrenska
Universitetssjukhuset, Göteborg
• Docent Lars Wennberg, Karolinska Universitetssjukhuset,
Stockholm
• Dr Ragnar Källén, Skånes Universitetssjukhus, Malmö
• Docent Lars Bäckman, Dr Mats Bengtsson, Akademiska
sjukhuset, Uppsala
• Ssk Anne-Karin Asperheim Sandberg, Karolinska
Universitetssjukhuset, Stockholm
Med ekonomiskt stöd från Vävnadsrådet (Vävnadsområdesgrupp-organ, VoGOrgan)
Swedish Pilot Program
• Meeting with Al Roth
• Five telephone conferences (Swedish pilot)
• Two meetings with SKL (VOG)
– National grant (Lars Bäckman)
• Two national meetings
• One national tissue typer meeting
• Presentations at the Annual Meetings of the:
– Swedish Transplantation Society
– Swedish Society For Renal Medicine
• Presentations at the Annual Meeting of the Swedish Kidney
Association
• Public Communication (Swedish Radio)
• Etc.
STEPOne
(matching program by Tommy Andersson)
All small step for (a) man. A giant leap for mankind
(in fact, its debated whether Neil Armstrong said ”a man”
or (in the heat of the monent) got it wrong and just said ”man”)
iSMART
(clinical organ exchange program by Ragnar Källén)
• Secure web access (Siths card?)
• Used for National Organ Coordination (DD)
– STEP module
• All relevant clinical data
• All necessary process data
Clinical protocol
• Version 1.6 May 16, 2015
• Preliminary
• Purpose
– To increase the likelihood of offering a suitable
kidney graft to immunized (HI) recipients who are
crossmatch positive against their living donor or
AB0-incompatible, thus reducing their time on the
waiting list.
Clinical Protocol
• Patients and donors are handled locally and
according to local routines and traditions
Clinical Protocol
• Success criteria
– Programme launched
– Planned exchange cycles are executed without
major obstacles
– Survival of grafts comparable to (or better than)
that in other immunized patients with similar PRAlevels
– Donor and recipient satisfaction
Clinical Protocol
• Transplants centres:
– Must be Organ Procurement and Transplantation
Centre within Scandiatransplant
– Must have a designated contact for the Program
– Must agree to abide the rules for the program
Clinical Protocol
• Recipient criteria:
– Adult patients that are eligible (or accepted to the
waiting list) for a kidney transplant and are
receiving care at a transplant centre within the
Nordic countries can join.
– Patients do not have to be on dialysis to join.
– Patients must have a incompatible (and therefore
unsuitable) but otherwise medically acceptable
living donor who is willing to donate a kidney
within the STEP programme
Clinical Protocol
• Donor criteria: (recommended under normal
circumstances, may be discussed in specific cases)
– The donor must be fully informed and willing to take part in an
exchange. Like any living donation program, all potential donors
are required to complete an extensive medical and
psychological evaluation to decide if they are acceptable as
kidney donors.
– A GFR above 80 ml/min/1.73m2 measured by a tracer (not
calculated)
– Sitting untreated BP <140/90 mmHg or 24 h BP <130/80 mmHg.
– No Diabetes.
– No Proteinuria
• Multiple donors are allowed
Clinical Protocol
• No specific information on donor identity can be given to
the recipient but general medical donor information may
be given during the consent process.
• All donors will receive a SCTP number that can be used for
traceability in the recipient medical files.
• Both the donor and the recipient in both (all) exchange
pairs need to be accepted by both Transplant teams
involved (for important factors such as age, kidney
function, prior medical conditions, anatomical details etc.)
– ”Clinical veto”
• Donors must be reported to the SCTP living donor database
and followed up after donation according to local and bestpractice guidelines
Clinical Protocol
• Informed Consent Requirements (valid for one year)
• For candidates:
– A transplant centre representative must review the components of the
Program with the candidate separately from the paired potential living
donor. After review, the transplant centre will ask the candidate to sign
a consent form.
– If the candidate chooses to accept a shipped kidney, the transplant
centre must have a signed consent form showing that the candidate
has been informed of the potential risks of shipping a kidney
• For potential living donors:
– For any exchange, the Transplant Hospital evaluating the potential
donor is responsible for receiving informed consent from potential
donors (including the risk that surgery may not occur due to
unforeseen events in the operating room)
Clinical Protocol
• The recipient will remain on the deceased donor waiting
list even if the recipient and donor joins the STEPprogramme.
• If the donor-recipient pair are found to have a potential
exchange pair after a match run, the recipients will be
temporarily deactivated on the waiting list.
• When a paired exchange has taken place they will be
removed from the waiting list. If the paired exchange is
cancelled they will be reactivated on the waitinglist.
• Match runs will be performed at regular intervals and the
time interval between match runs will be decided
dependent of the number of participants in the program
(>15 or every 3rd month)
Clinical Protocol
• Coordination
– Coordinating teams from both (all)
Transplantation units involved need to
communicate, plan and coordinate all required
exchange activities (such as surgical operations,
communication, transport etc.) in good advance.
Clinical Protocol
• Operative procedure, preservation and transportation:
– In a kidney exchange both (all) donor operations will start
simultaneously.
– Before start of the surgery and before vascular clamping
and organ removal telephone calls will take place between
the two (all) operations rooms to verify and synchronize
activities.
– The donor kidneys will be preserved according to
agreement and transported to the recipient centre as soon
as possible.
– The start of the donor operations could be adjusted to fit
regular flights.
Shipping of Kidneys for exchange
Shipping of Kidneys for exchange
Mean CIT of 12.1 ± 2.8 h.
Immunology
• Utredning av patienten inför parvis njurdonation:
– HLA-typning: A,B,C,DRB1,DR3/4/5, DQA1,DQB1,DPA1,DPB1
(hög upplösning). Information om såväl genomisk HLA-typ samt
serologisk motsvarighet skall kunna föras in i databasen.
– Definition av panel-reaktiva HLA-antikroppar (PRA) hos
patienten. Analys sker med Luminex Single-antibody eller
motsvarande teknik. Information om såväl förekomst av
donator-specifika antikroppar samt eventuella upprepade
mismatcher skall kunna föras in i databasen.
• Utredning av donatorn inför parvis njurdonation:
– HLA-typning: A,B,C,DRB1,DR3/4/5, DQA1,DQB1,DPA1,DPB1
(hög upplösning). Information om såväl genomisk HLA-typ samt
serologisk motsvarighet skall kunna föras in i databasen.
Immunology
• Önskemål om patient- och donatorsuppgifter till
utbytesprogrammet:
– Notering av HLA-typ med fyra siffrors noggrannhet på
både patient och donator.
– Notering av de genomiska HLA-typernas serologiska
motsvarigheter (1-2 siffror).
– Notering av förekomst av panel-reaktiva antikroppar för
HLA klass I och II.
– Notering av eventuella upprepade mismatcher (även utan
förekomst av donator-specifika antikroppar (DSA).
– Notering av patientens och donatorns ålder, kön och deras
relation (partner, syskon, föräldrar etc).
ABO
• ABO-incompatible pairs allowed
• ABO compatibility prioritized in the optimizing
matching allgorithm
• ABO-incompatible exchanges allowed
Accepting ABO-incompatible matching
• Accepting ABO-incompatibility to avoid
HLA-incompatibility
– Allowing ABO-incompatible matching significantly
improves match rates
• Auistralian KPD program 2010-2012
– Without ABOI = 27 RTx
– Accepting ABOi = 48 RTx
Ferrari et al, Transplant 2013; 96: 821-826
Accepting ABO-incompatible matching
• There has been a reduction in the number of
(only) ABO-incompatible pairs participating in
kidney exchange programs
– Excellent outcome in patients recieving a kidney
from a directed ABO-incompatible donor and if
there are no anti-HLA DSA
– ABO-incompatible RTx has become standard
practice in many centers
• ”We are the victims of our own success”
Clinical Protocol
• Compensation:
– All costs for both recipient and donor (including
necessary immunological work-up etc.) are
covered by the local Transplantation unit.
– Costs for transport is covered by the receiving
Transplantation unit.
Clinical Protocol
• The Optimization Matching Algorithm:
– In the start of the program, only paired exchanges
(2-way-exchanges) will be performed.
– When the program is implemented and the Nordic Kidney
Group decides so, 3-way-exchanges, chains and altruistic
donors will be allowed in the matching algorithm.
– The algorithm will prioritize (in order):
1. The number of transplanted patients
2. Low ”Transplantability Score” (according to SCTP database)
– The chance for a patient to recieve an ABO-identical and HLA-compatible
kidney
– Virtual PRA (1000 most recent DD) combined with ABO-type
– All patients must be in SCTP database
3. Short cycles (later)
4. Compatible blood groups
– Anti-ABOi IgG <64 accepted?
Patient and donor information
• Basic written information discussed and
developed (preliminary version)
• Local / national adaptation
• Information to professionals necessary
Status Swedish pilot program
• (Almost) ready to start
• Incompatible LD-pairs are investigated and
included at all Swedish centers
• Remaining issues
– Computer programming
– Web access
