Kidneys for Transplant Function Earlier and Last Longer When Preserved in a Machine Compared to the Traditional Box of Ice

Groningen, The Netherlands (ots/PRNewswire) - Results
from a landmark trial published today in the New England Journal of
Medicine, show that in transplanted kidneys preserved and transported
in a specially designed machine (LifePort Kidney Transporter) the
odds for experiencing a delay in recovery of kidney function are 43%
lower, and that these kidneys are 48% less likely to fail within a
year compared to those stored in the traditional box of ice (cold
storage)(1). The study was the first randomised, prospective trial to
compare these two methods of preservation.

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Depending on the type of deceased donor,* 15-50 per cent of
transplanted kidneys do not function immediately following
transplantation and many patients will require dialysis treatments
for a certain period after transplantation(2,3,4). As a result, these
kidneys have an increased risk of rejection(3) and survival of the
kidney graft may be compromised. This in turn will put pressure on
the already long transplant waiting lists(3,4).

"This is a truly important finding for the thousands of people on
transplant waiting lists around the world", said Rutger Ploeg,
coordinating principal investigator for the trial and Professor of
Transplant Surgery at the University Medical Center Groningen, The
Netherlands. "The ongoing challenges we face today are a global
shortage of organs for transplantation and that a growing number of
the organs available for transplantation are often from older donors
or from people with more complex medical conditions. Evidence tells
us that these kidneys may not work as well immediately post
transplantation and as a result may not last as long. This trial
shows us that, regardless of the type of donor, by using machine
preservation we can ensure that there will be more kidneys available
for transplantation and that they will be in better health."

Cyril Moers, lead author and clinical research trainee at the
University Medical Center Groningen, added "The results of the study
clearly show the advantages of machine preservation over the
traditional box of ice. Although machine preservation has been around
for quite some decades, a large randomised clinical trial
investigating its merits had never been conducted. Our international
study for the first time demonstrates that any deceased donor kidney
will benefit from this preservation method."

Facts about the trial

- The Machine Preservation Trial was an investigator-driven
study, run by an independent scientific steering committee across The
Netherlands, Belgium and the German federal state of North Rhine
Westphalia, in close collaboration with Eurotransplant International
Foundation (the international organ exchange organisation for
Austria, Belgium, Croatia, Germany, Luxembourg, The Netherlands and
Slovenia) as the central trial assistance desk. Principal
investigators were Rutger Ploeg (Groningen, The Netherlands), Andreas
Paul (Essen, Germany), and Jacques Pirenne (Leuven, Belgium).

- During the time of the trial, every deceased donor in the area
was considered for inclusion in the study. 336 pairs of kidneys were
enrolled in the study. One kidney from each pair was randomly
assigned to machine preservation, and the other one to cold storage.
Kidneys were transplanted in recipients across the Eurotransplant
area.

- The manufacturers, Organ Recovery Systems of Chicago, USA
provided the LifePort Kidney Transporters used in the study. The
machines were used for the preservation and transport of kidneys from
organ recovery until transplantation.

Study Endpoints

- The primary endpoint was delayed graft function defined as the
need for dialysis in the first week post transplantation. Evidence
suggests that organs that do not function immediately after
transplantation have an increased risk of rejection and survival of
the transplanted kidney may be inferior.(2)

- Secondary endpoints included: patient and graft survival up to
12 months after transplantation, duration of delayed graft function,
length of stay in hospital, primary non-function of the transplanted
kidney, serum creatinine and clearance after transplantation, acute
rejection and calcineurin inhibitor toxicity.

Results from the study

- Machine perfusion significantly reduced the risk of delayed
graft function compared to cold storage. 70 out of 336 kidney
recipients in the machine perfusion group developed delayed graft
function compared with 89 out of 336 patients in the cold storage
group (adjusted odds ratio 0.57; P=0.01).

- In case delayed graft function occurred, its duration was
shorter after machine perfusion compared with cold storage (10 days
vs. 13 days; P=0.03).

- One year graft survival was superior in the machine perfusion
group (94% vs. 90%; P=0.04) and machine perfusion was associated with
a reduced risk of graft failure in the first year post-transplant
(hazard ratio 0.52; P=0.03).

- Serum creatinine values were significantly lower for machine
perfused kidney recipients compared to those cold stored in the first
two weeks post transplantation (P=0.01).

- There were no significant differences observed for the other
secondary endpoints.

- No serious adverse events were directly attributable to
machine perfusion.

Facts about transplantation

- More than 1.5 million people worldwide suffer from end stage
renal disease.(5)

- In 2008 in the USA alone, for example there are currently
82,435 people waiting for a kidney transplant. This year 4,213
kidneys have been recovered from deceased donors(6)

- Eurotransplant International Foundation (Eurotransplant) is the
international organ exchange organisation for Austria, Belgium,
Croatia, Germany, Luxembourg, The Netherlands and Slovenia and serves
a population of 118 million.

- In the Eurotransplant area there are currently 10,719 people
waiting for a kidney transplant (active waiting list of September 30,
2008)(7).

- In 2007, 3,420 people received a kidney transplant in the
Eurotransplant region(7).

Notes to Editors:

* Deceased donors include:

- Brain dead donors - patients who meet the legal and medical
criteria for brain stem death, whose organs are removed for
transplantation.

- Donors after cardiac death (DCD) - organ donors who have
been declared dead because their heart has stopped (also called
non-heart-beating donors) .

- Expanded criteria donors (ECD) - brain dead donors or donors
after cardiac death over the age of 60 years, or between 50 and 60
years with additional health conditions such as high blood pressure,
stroke, or a sub-optimal kidney function prior to organ retrieval.

Trial organisational structure

Scientific steering committee

Rutger J. Ploeg (coordination principal investigator, The
Netherlands)

Andreas Paul (principal investigator, North Rhine Westphalia,
Germany)

Jacques Pirenne (principal investigator, Belgium)

Cyril Moers (secretary)

Mark-Hugo Maathuis (regional perfusion center liaison)

Jaap Homan van der Heide (member)

Ernst van Heurn (member)

Jean-Paul Squifflet (member)

Jürgen Treckmann (member)

Central trial assistance

Arie Oosterlee (Eurotransplant, general director)

Axel Rahmel (Eurotransplant, medical director)

Jacqueline Smits (Eurotransplant, statistician)

Margitta van Kasterop-Kutz (Eurotransplant, data manager)

Günter Kirste (Deutsche Stiftung Organtransplantation, general
director)

Ulrike Wirges (Deutsche Stiftung Organtransplantation,
director North Rhine Westphalia)

Regional perfusion center coordinators

Henri Leuvenink (Groningen, The Netherlands)

Frank van Gelder (Leuven, Belgium)

Bogdan Napieralski (Essen, Germany)

---------------------------------

(1) Moers C, Smits JM, Maathuis M-H J et al. Machine perfusion or
cold storage in deceased donor kidney transplantation. New England
Journal of Medicine 1. N Engl J Med 2009; 360:7-19

(2) Koning OH, Ploeg RJ, van Bockel JH et al. Risk factor for
delayed graft function in cadaveric kidney transplantation: a
prospective study of renal function and graft survival after
preservation with University of Wisconsin solution in
multi-organ-donors. European Multicenter Study Group.
Transplantation. 1997 Jun 15;63(11):1620-8.

(3) Daly PJA, Power RE, Healy DA et al. Delayed graft
function: a dilemma in renal transplantation. BJU International
2005;96:498-501.

(4) Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft
function in kidney transplantation. Lancet 2004; 364: 1814.

(5) http://www.worldkidneyday.org/pages/facts.php

(6) http://www.optn.org

(7) http://www.eurotransplant.eu

ots Originaltext: Scientific Steering Committee, Machine Preservation Trial
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information or to request an interview with Professor
Rutger Ploeg please contact: Press office: Mobile: +44-7-941989955 or
University Medical Center Groningen, Department of Media
Communication, Phone: +31-50-3616161