Abstract
Objectives: Reducing the incidence of delayed graft
function after transplant with donation after cardiac
death donor renal allografts would facilitate
managing recipients during their first weeks after a
transplant. To reduce this incidence, in most studies,
induction therapy with depleting anti-T-lymphocyte
antibodies is coupled with a reduction of the dosage
of the calcineurin inhibitor. The separate effect of
anti-T-cell therapy on the incidence and duration of
delayed graft function is therefore difficult to assess.
Patients and Methods: We performed a randomized
study to evaluate the effect of a single intraoperative
high-dose of anti-T-lymphocyte immunoglobulin
(ATG)-Fresenius (9 mg/kg body weight) on the
incidence of delayed graft function. Eligible adult
recipients of a first donation after cardiac death
donor renal allograft were randomly assigned to
ATG-Fresenius or no induction therapy. Maintenance
immunosuppression consisted of tacrolimus, in an
unadjusted dose, mycophenolate mofetil, and
steroids.
Results: The study was prematurely terminated
because of a lower-than-anticipated inclusion rate.
Baseline characteristics were comparable in the
ATG-Fresenius group (n=28) and the control group
(n=24). Twenty-two patients in the ATG-Fresenius
group (79%) had delayed graft function, compared
with 13 in the control group (54%; P = .06). Allograft
and patient survival were comparable in both
groups. Serious adverse events occurred more
frequently in the ATG-Fresenius group than they did
in the control group (57% vs 29%; P < .05).
Conclusions: Intraoperative administration of a
single high-dose of ATG-Fresenius in donation after
cardiac death donor renal allograft recipients,
followed by triple immunosuppression with an
unadjusted tacrolimus dose, seems ineffective to
reduce the incidence of delayed graft function.
Moreover, this was associated with a higher
rate of serious adverse events (EudraCT-number,
2007-000210-36.)
Key words: Anti-T-lymphocyte immunoglobulin,
Delayed graft function, Donation after cardiac death
Introduction
The increased waiting list for renal transplant has
prompted the use of so-called “expanded criteria
donors” to increase the number of renal allografts
available for transplant. Donation after cardiac death
(DCD) has emerged as a satisfactory option to provide
renal allografts with patient and graft survival rates
similar to those obtained with renal allografts from
donation after brain death donors.
1
A major problem
aRTICLE
Effect of a Single Intraoperative High-Dose ATG-Fresenius
on Delayed Graft Function in Donation After
Cardiac-Death Donor Renal Allograft Recipients:
A Randomized Study
Martijn W. F. van den Hoogen,
1
Marcia M. L. Kho,
2
Alferso C. Abrahams,
3
Arjan D. van Zuilen,
3
Jan-Stephan Sanders,
4
Marja van Dijk,
4
Luuk B. Hilbrands,
1
Willem Weimar,
2
Andries J. Hoitsma
1
DOI: 10.6002/ect.2012.0220 Copyright © Başkent University 2013
Printed in Turkey. All Rights Reserved.
From the
1
Department of Nephrology, Radboud University Nijmegen Medical Centre; the
2
Department of Nephrology, Erasmus Medical Centre Rotterdam;
3
Department of Nephrology,
University Medical Centre Utrecht; and the
4
Department of Nephrology, University Medical
Centre Groningen, The Netherlands
Acknowledgements: This study was financially supported by Fresenius Biotech GmbH,
Gräfelfing, Germany. The company had no input in study design, data collection, data analysis,
and writing or editing of the manuscript. We thank Marjo van Helden and Judith Kal-van Gestel
for continually monitoring the study and managing the database, and we thank Ronald Hené for
his valuable comments.
Corresponding author: M. W. F. van den Hoogen, Department of Nephrology 464, Radboud
University Nijmegen Medical Centre, Geert Grooteplein 8, 6525 GA Nijmegen, The Netherlands
Phone: +31 24 361 4761 Fax: +31 24 354 0022
E-mail: m.vandenhoogen@aig.umcn.nl
Experimental and Clinical Transplantation (2013) 2: 134-141