ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus

Franco Citterio, Oleg O. Rummo, Mario Carmellini, Lionel Rostaing, Rainer Oberbauer, Maarten H. L. Christiaans, Christiane Mousson, Robert M. Langer, Bernard Charpentier, Malcolm Brown, Gbenga Kazeem, Frank Lehner, Munish Heer, Wai Lim, Ferdinand Mühlbacher, Johann Pratschke, Cathérine Bonvoisin, Dirk Kuypers, Jarmila Dedochova, Milan KumanYann Le Meur, Patrice Deteix, Luc Frimat, Philippe Lang, Yvon Lebranchu, Christophe Legendre, Pierre Francois Westeel, Peter Schenker, Karl-Friedrich Hilgers, Oliver Witzke, Ingeborg Hauser, Volker Kliem, Martin Zeier, Ulrich Kunzendorf, Michael Bartels, Sven Jonas, Markus Guba, Heiner H. Wolters, Tak-Mao Chan, Flavia Caputo, Vito Sparacino, Michal Nowicki, Maciej Glyda, Yu Seun Kim, Jongwon Ha, Chan Duck Kim, Duck Jong Han, Yeong Hoon Kim, Dmitry Perlin, Alexander Sal'Mayer, Sergey B. Semchenko, Igor Nesterenko, Antonio Franco, Josep Grinyó, Ainhoa Inza, Juan Carlos Ruiz, Yang-Jen Chiang, Po-Chang Lee, Gultekin Suleymanlar, Sinasi Sevmis, Serdar Kacar

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11 Citations (Scopus)

Abstract

ADHERE was a randomized, open-label, Phase IV study comparing renal function at Week 52 postkidney transplant, in patients who received prolonged-release tacrolimus-based immunosuppressive regimens. On Days 0–27, patients received prolonged-release tacrolimus (initially 0.2 mg/kg/day), corticosteroids, and mycophenolate mofetil (MMF). Patients were randomized on Day 28 to receive either prolonged-release tacrolimus plus MMF (Arm 1) or prolonged-release tacrolimus (≥25% dose reduction on Day 42) plus sirolimus (Arm 2). The primary endpoint was glomerular filtration rate by iohexol clearance (mGFR) at Week 52. Secondary endpoints included eGFR, creatinine clearance (CrCl), efficacy failure (patient withdrawal or graft loss), and patient/graft survival. Tolerability was analyzed. The full-analysis set comprised 569 patients (Arm 1: 287; Arm 2: 282). Week 52 mean mGFR was similar in Arm 1 versus Arm 2 (40.73 vs. 41.75 ml/min/1.73 m2; P = 0.405), as were the secondary endpoints, except composite efficacy failure, which was higher in Arm 2 versus 1 (18.2% vs. 11.5%; P = 0.002) owing to a higher postrandomization withdrawal rate due to adverse events (AEs) (14.4% vs. 5.2%). Results from this study show comparable renal function between arms at Week 52, with fewer AEs leading to study discontinuation with prolonged-release tacrolimus plus MMF (Arm 1) versus lower dose prolonged-release tacrolimus plus sirolimus (Arm 2).
Original languageEnglish
Pages (from-to)83-95
Number of pages13
JournalTransplant International
Volume30
DOIs
Publication statusPublished - 2017

Keywords

  • Transplantation
  • calcineurin antagonists
  • immunosuppression
  • kidney clinical
  • outcome

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