ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged‐release tacrolimus plus mycophenolate mofetil or sirolimus. (28th November 2016)

• Record Type: Journal Article
• Authors: Rummo, Oleg O.; Carmellini, Mario; Rostaing, Lionel; Oberbauer, Rainer; Christiaans, Maarten H. L.; Mousson, Christiane; Langer, Robert M.; Citterio, Franco; Charpentier, Bernard; Brown, Malcolm; Kazeem, Gbenga; Lehner, Frank
• Other Names: Heer Munish investigator.; Lim Wai investigator.; Mühlbacher Ferdinand investigator.; Pratschke Johann investigator.; Bonvoisin Cathérine investigator.; Kuypers Dirk investigator.; Dedochova Jarmila investigator.; Kuman Milan investigator.; Le Meur Yann investigator.; Deteix Patrice investigator.; Frimat Luc investigator.; Lang Philippe investigator.; Lebranchu Yvon investigator.; Legendre Christophe investigator.; Westeel Pierre Francois investigator.; Schenker Peter investigator.; Hilgers Karl‐Friedrich investigator.; Witzke Oliver investigator.; Hauser Ingeborg investigator.; Kliem Volker investigator.; Zeier Martin investigator.; Kunzendorf Ulrich investigator.; Bartels Michael investigator.; Jonas Sven investigator.; Guba Markus investigator.; Wolters Heiner H. investigator.; Chan Tak‐Mao investigator.; Caputo Flavia investigator.; Sparacino Vito investigator.; Nowicki Michal investigator.; Glyda Maciej investigator.; Kim Yu Seun investigator.; Ha Jongwon investigator.; Kim Chan Duck investigator.; Han Duck Jong investigator.; Kim Yeong Hoon investigator.; Perlin Dmitry investigator.; Sal'mayer Alexander investigator.; Semchenko Sergey B. investigator.; Nesterenko Igor investigator.; Franco Antonio investigator.; Grinyó Josep investigator.; Inza Ainhoa investigator.; Ruiz Juan Carlos investigator.; Chiang Yang‐Jen investigator.; Lee Po‐Chang investigator.; Suleymanlar Gultekin investigator.; Sevmis Sinasi investigator.; Kacar Serdar investigator.;
• Is Part Of: Transplant international. Volume 30:Number 1(2017)
• Page Start: 83
• Page End: 95
• Publication Date: 2016-11-28
• Subjects: calcineurin antagonists -- immunosuppression -- kidney clinical -- outcome; Transplantation of organs, tissues, etc -- Periodicals; 617.95405
• DOI: 10.1111/tri.12878
• Languages: English
• ISSNs: 0934-0874

Abstract

Summary: 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 m 2 ; 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).