Title Participants Abstract "Redefining Risk Stratification and Endpoints for Clinical Trials in Kidney Transplantation: Rationale and Methodology of Proposals Submitted to the European Medicines Agency by the European Society for Organ Transplantation" "Maarten Naesens" "The European Society for Organ Transplantation (ESOT) submitted a Broad Scientific Advice request to the European Medicines Agency (EMA) in 2018, to explore whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research, thereby improving long-term outcomes for allograft recipients. The request was refined collaboratively by the EMA and ESOT, with the EMA issuing a final response in December 2020. This Transplant International special issue explores the topics that were the focus of these interactions between the EMA and ESOT. Articles explore the current issues and dilemmas in kidney transplantation, primarily relating to unclear or outdated risk stratification and markers of transplantation success, although several potential improvements for outcomes assessment are also suggested. Discussions between the EMA and ESOT and recommendations are summarized, in the hope that this project will generate further discussion eventually generating a consensus on clinical trial endpoints and risk stratification, increase the quality of research in transplantation medicine, and improve long-term outcomes for kidney transplant recipients." "Advancing Transplantation: New Questions, New Possibilities in Kidney and Liver Transplantation" "Dirk Kuypers, Jacques Pirenne" "Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. Disclosure and contributions: This supplement collects a number of the sessions from the meeting 'Advancing Transplantation: New Questions, New Possibilities'. The meeting was sponsored by Astellas Pharma Europe Ltd; the agenda was developed by Astellas in collaboration with the meeting's scientific committee: J Wadström, BG Ericzon, WO Bechstein, D Serón and PF Halloran. The event was approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 12 category 1 (external) CPD credits. The scientific committee and faculty developed their own content for the meeting with editorial support from iS Health Group. Editorial support for the meeting was funded by Astellas Pharma Europe Ltd. Previously unpublished data that could not be included, due to existing embargo policies or to protect intellectual property, have been excluded from this report. The unpublished data in this report were included at the discretion of the authors as personal communications. Based on the presentations given at the meeting and under the direction of the authors, iS LifeScience provided editorial support throughout the development of this supplement. Editorial support was funded by Astellas Pharma Europe Ltd. A.L., in his role as the Guest Editor, reviewed this supplement and advised on the content throughout the development process. The authors had final authority over the editorial content and approved the final version of this supplement before submission. Astellas Pharma and associated companies developed, manufacture and supply tacrolimus (tacrolimus hard capsules (Prograf), tacrolimus prolonged-release hard capsules (Advagraf)). Prescribing information and adverse event reporting information can be found on pages S40-S41. J.W. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. B-G.E reports nonfinancial support from Astellas, during the development of this supplement; honoraria and consultancy fees from Astellas, Pfizer and Novartis and clinical trial support from Novartis and Astellas, outside of the submitted work. P.H. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work shares in TSI, a university company with an interest in molecular diagnostics. W.B. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. G.O. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work D.S. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work J.G. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. A.L. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. D.K. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work CM. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. M.C. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. A.J. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, Opsona Therapeutics, AstraZeneca, Bayer and Pfizer, outside the submitted work. L.G. reports personal fees from Astellas during the conduct of the study for acting as a conference speaker; personal fees from Astellas, personal fees from Novartis, personal fees from Pfizer, personal fees from Roche, outside the submitted work. B.F. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, grants from BMS, grants and consulting fees from Pharmalink, and lecturing fees from Sandoz, outside of the submitted work. J.O.G. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. J.P. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. J.O.L. reports nonfinancial support from Astellas, during the development this supplement; nonfinancial support and personal fees from Astellas, personal fees from Novartis, and grants from Fisher Scientific, outside of the submitted work. V.A. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. P.T. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. U.B. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support from and personal fees from Astellas, outside the submitted work. J.N. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, and personal fees from Novartis, outside of the submitted work; employment as a consultant physician at Queen Elizabeth Hospital, Birmingham. A.S.-G. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support and personal fees from Astellas, outside of the submitted work. E.G. reports nonfinancial support from Astellas, during the development of this supplement; nonfinancial support from Astellas, and personal fees from Astellas, Pfizer and Novartis, outside the submitted work. M.M. reports nonfinancial support from Astellas, during the development of this supplement; non-financial support and personal fees from Astellas, outside of the submitted work. M.G. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support from Astellas and personal fees from Astellas, outside the submitted work." "Therapeutic drug monitoring of mycophenolates in kidney transplantation: report of The Transplantation Society consensus meeting" "Dirk Kuypers" "Transplantation: BENEFIT of belatacept: kidney transplantation moves forward" "Maarten Naesens" "Does kidney donor risk index implementation lead to the transplantation of more and higher-quality donor kidneys?" "Ester Philipse, Alison P. K. Lee, Bart Bracke, Vera Hartman, Geert Roeyen, Kathleen De Greef, Dirk Ysebaert, G. Van Beeumen, Marie Couttenye, Amaryllis Van Craenenbroeck, Jean-Louis Bosmans, Daniel Abramowicz" "Background. The Kidney Donor Risk Index (KDRI) is a quantitative evaluation of the quality of donor organs and is implemented in the US allocation system. This single-centre study investigates whether the implementation of the KDRI in our decision-making process to accept or decline an offered deceased donor kidney, increases our acceptance rate. Methods. From April 2015 until December 2016, we prospectively calculated the KDRI for all deceased donor kidney offers allocated by Eurotransplant to our centre. The number of the transplanted versus declined kidney offers during the study period were compared to a historical set of donor kidney offers. Results. After implementation of the KDRI, 26.1% (75/288) of all offered donor kidneys were transplanted, compared with 20.7% (136/657) in the previous period (P < 0.001). The median KDRI of all transplanted donor kidneys during the second period was 0.97 [Kidney Donor Profile Index (KDPI) 47%], a value significantly higher than the median KDRI of 0.85 (KDPI 34%) during the first period (P = 0.047). A total of 68% of patients for whom a first-offered donor kidney was declined during this period were transplanted after a median waiting time of 386 days, mostly with a lower KDRI donor kidney. Conclusions. Implementing the KDRI in our decision-making process increased the transplantation rate by 26%. The KDRI can be a supportive tool when considering whether to accept or decline a deceased donor kidney offer. More data are needed to validate this score in other European centres." "Evolution of Kidney Function after Liver Transplantation for Adult Polycystic Liver Disease and Indications for Combined Liver and Kidney Transplantation" "Tom Darius, Eliano Bonaccorsi, Monbaliu Diethard, Alexandre Patris, Willy Coosemans, Tania Roskams, Ziad Hassoun, Olga Ciccarelli, Yves Pirson, Yves Vanrenterghem, Frederik Nevens, Jan Lerut, Jacques Pirenne" "Does pre-emptive transplantation versus post start of dialysis transplantation with a kidney from a living donor improve outcomes after transplantation? : a systematic literature review and position statement by the Descartes Working Group and ERBP" "Daniel Abramowicz, Marc Hazzan, Umberto Maggiore, Licia Peruzzi, Pierre Cochat, Rainer Oberbauer, Maria C Haller, for the Descartes Board, for the ERBP Advisory Board, Evi Nagler, Raymond Vanholder" "High-urgency kidney transplantation in the Eurotransplant Kidney Allocation System : success or waste of organs? : the Eurotransplant 15-year all-centre survey" "Volker Assfalg, Norbert Hueser, Marieke van Meel, Bernhard Haller, Axel Rahmel, Jan de Boer, Edouard Matevossian, Alexander Novotny, Noel Knops, Laurent Weekers, Helmut Friess, Johann Pratschke, Reinhold Fuegger, Otmar Janko, Susanne Rasoul-Rockenschaub, Jean-Louis Bosmans, Nilufer Broeders, Michel Mourad, Dirk Kuypers, Jasna Slavicek, Anja Muehlfeld, Florian Sommer, Richard Viebahn, Andreas Pascher, Markus van der Giet, Frans Zantvoort, Rainer P Woitas, Juliane Putz, Klaus Grabitz, Andreas Kribben, Ingeborg Hauser, Przemyslaw Pisarski, Rolf Weimer, Thomas Lorf, Paola Fornara, Christian Morath, Bjoern Nashan, Frank Lehner, Volker Kliem, Urban Sester, Marc-Oliver Grimm, Thorsten Feldkamp, Robert Kleinert, Wolfgang Arns, Christian Moench, Markus Bo Schoenberg, Martin Nitschke, Bernd Krueger, Stefan Thorban, Helmut P Arbogast, Heiner H Wolters, Tanja Maier, Jens Lutz, Katharina Heller, Bernhard Banas, Oliver Hakenberg, Martin Kalus, Silvio Nadalin, Frieder Keller, Kai Lopau, Frederike Jose Bemelman, Shaikh Nurmohamed, Jan-Stephan Sanders, Johan W de Fijter, Maarten Christiaans, Luuk Hilbrands, Michiel Betjes, Arjan van Zuilen, Uwe Heemann" "Kidney Versus Combined Kidney and Liver Transplantation in Young People With Autosomal Recessive Polycystic Kidney Disease: Data From the European Society for Pediatric Nephrology/European Renal Association-European Dialysis and Transplant (ESPN/ERA-EDTA)" "Djalila Mekahli, Jacques Pirenne" "The choice for either kidney or combined liver-kidney transplantation in young people with kidney failure and liver fibrosis due to autosomal recessive polycystic kidney disease (ARPKD) can be challenging. We aimed to analyze the characteristics and outcomes of transplantation type in these children, adolescents, and young adults." "Supplemented ERA-EDTA registry data evaluated the frequency of dialysis, kidney transplantation and comprehensive conservative management for patients with kidney failure in Europe" "Vianda S. Stel, Rianne W. de Jong, Anneke Kramer, Anton M. Andrusev, José M. Baltar, Myftar Barbullushi, Samira Bell, Pablo Castro de la Nuez, Harijs Cernevskis, Cécile Couchoud, Johan De Meester, Bjørn O. Erikson, Liliana Garneata, Eliezer Golan, Jaakko Helve, Marc H. Hemmelder, Kristine Hommel, Kyriakos Ioannou, Faiçal Jarray, Nino Kantaria, Julia Kerschbaum, Kirill S. Komissarov, Ángela Magaz, Lucile Mercadal, Mai Ots-Rosenberg, Runólfur Palsson, Axel Rahmel, Helena Rydell, Manuela Savino, Nurhan Seyahi, Maria F. Slon Roblero, Olivera Stojceva-Taneva, Arjan van der Tol, Evgueniy S. Vazelov, Edita Ziginskiene, Óscar Zurriaga, Raymond Vanholder, Ziad A. Massy, Kitty J. Jager"