PMID- 27754567 OWN - NLM STAT- MEDLINE DCOM- 20170817 LR - 20220408 IS - 1432-2277 (Electronic) IS - 0934-0874 (Linking) VI - 30 IP - 1 DP - 2017 Jan TI - ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus. PG - 83-95 LID - 10.1111/tri.12878 [doi] AB - 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). CI - (c) 2016 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT. FAU - Rummo, Oleg O AU - Rummo OO AD - Republican Scientific and Practical Center (RSPC) for Organ and Tissue Transplantation, Minsk, Belarus. FAU - Carmellini, Mario AU - Carmellini M AD - Department of Medical, Surgical and Neuroscience, Policlinico Santa Maria alle Scotte, University of Siena, Siena, Italy. FAU - Rostaing, Lionel AU - Rostaing L AD - Department of Nephrology, Dialysis and Organ Transplantation, Toulouse University Hospital, INSERM U563, IFR-BMT, CHU Purpan, Toulouse, France. FAU - Oberbauer, Rainer AU - Oberbauer R AD - Department of Internal Medicine III, Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria. FAU - Christiaans, Maarten H L AU - Christiaans MH AD - Department of Internal Medicine/Division of Nephrology, Maastricht University Medical Center, Maastricht, The Netherlands. FAU - Mousson, Christiane AU - Mousson C AD - Department of Nephrology-Transplantation, University Hospital, Dijon, France. FAU - Langer, Robert M AU - Langer RM AD - Department of Transplantation and Surgery, Semmelweis University, Budapest, Hungary. FAU - Citterio, Franco AU - Citterio F AD - Department of Surgery, Renal Transplantation, Catholic University, Rome, Italy. FAU - Charpentier, Bernard AU - Charpentier B AD - Department of Nephrology, Dialysis and Transplantation, University Hospital of Bicetre, Le Kremlin Bicetre, France. FAU - Brown, Malcolm AU - Brown M AD - Medical Affairs - Global, Astellas Pharma, Northbrook, IL, USA. FAU - Kazeem, Gbenga AU - Kazeem G AD - Astellas Pharma Europe Ltd, Chertsey, UK. FAU - Lehner, Frank AU - Lehner F AD - General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany. CN - ADHERE study investigators LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20161128 PL - Switzerland TA - Transpl Int JT - Transplant international : official journal of the European Society for Organ Transplantation JID - 8908516 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Immunosuppressive Agents) RN - HU9DX48N0T (Mycophenolic Acid) RN - W36ZG6FT64 (Sirolimus) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Adrenal Cortex Hormones/therapeutic use MH - Adult MH - Aged MH - Female MH - Glomerular Filtration Rate MH - Graft Rejection MH - Graft Survival MH - Humans MH - Immunosuppressive Agents/*administration & dosage/therapeutic use MH - Kidney Failure, Chronic/immunology/*surgery MH - Kidney Function Tests MH - *Kidney Transplantation MH - Male MH - Middle Aged MH - Mycophenolic Acid/*administration & dosage MH - Sirolimus/*administration & dosage MH - Tacrolimus/*administration & dosage MH - Time Factors MH - Transplant Recipients MH - Treatment Outcome OTO - NOTNLM OT - calcineurin antagonists OT - immunosuppression OT - kidney clinical OT - outcome FIR - Heer, Munish IR - Heer M FIR - Lim, Wai IR - Lim W FIR - Muhlbacher, Ferdinand IR - Muhlbacher F FIR - Pratschke, Johann IR - Pratschke J FIR - Bonvoisin, Catherine IR - Bonvoisin C FIR - Kuypers, Dirk IR - Kuypers D FIR - Dedochova, Jarmila IR - Dedochova J FIR - Kuman, Milan IR - Kuman M FIR - Le Meur, Yann IR - Le Meur Y FIR - Deteix, Patrice IR - Deteix P FIR - Frimat, Luc IR - Frimat L FIR - Lang, Philippe IR - Lang P FIR - Lebranchu, Yvon IR - Lebranchu Y FIR - Legendre, Christophe IR - Legendre C FIR - Westeel, Pierre Francois IR - Westeel PF FIR - Schenker, Peter IR - Schenker P FIR - Hilgers, Karl-Friedrich IR - Hilgers KF FIR - Witzke, Oliver IR - Witzke O FIR - Hauser, Ingeborg IR - Hauser I FIR - Kliem, Volker IR - Kliem V FIR - Zeier, Martin IR - Zeier M FIR - Kunzendorf, Ulrich IR - Kunzendorf U FIR - Bartels, Michael IR - Bartels M FIR - Jonas, Sven IR - Jonas S FIR - Guba, Markus IR - Guba M FIR - Wolters, Heiner H IR - Wolters HH FIR - Chan, Tak-Mao IR - Chan TM FIR - Caputo, Flavia IR - Caputo F FIR - Sparacino, Vito IR - Sparacino V FIR - Nowicki, Michal IR - Nowicki M FIR - Glyda, Maciej IR - Glyda M FIR - Kim, Yu Seun IR - Kim YS FIR - Ha, Jongwon IR - Ha J FIR - Kim, Chan Duck IR - Kim CD FIR - Han, Duck Jong IR - Han DJ FIR - Kim, Yeong Hoon IR - Kim YH FIR - Perlin, Dmitry IR - Perlin D FIR - Sal'mayer, Alexander IR - Sal'mayer A FIR - Semchenko, Sergey B IR - Semchenko SB FIR - Nesterenko, Igor IR - Nesterenko I FIR - Franco, Antonio IR - Franco A FIR - Grinyo, Josep IR - Grinyo J FIR - Inza, Ainhoa IR - Inza A FIR - Ruiz, Juan Carlos IR - Ruiz JC FIR - Chiang, Yang-Jen IR - Chiang YJ FIR - Lee, Po-Chang IR - Lee PC FIR - Suleymanlar, Gultekin IR - Suleymanlar G FIR - Sevmis, Sinasi IR - Sevmis S FIR - Kacar, Serdar IR - Kacar S EDAT- 2016/10/19 06:00 MHDA- 2017/08/18 06:00 CRDT- 2016/10/19 06:00 PHST- 2016/05/06 00:00 [received] PHST- 2016/05/09 00:00 [revised] PHST- 2016/10/14 00:00 [accepted] PHST- 2016/10/19 06:00 [pubmed] PHST- 2017/08/18 06:00 [medline] PHST- 2016/10/19 06:00 [entrez] AID - 10.1111/tri.12878 [doi] PST - ppublish SO - Transpl Int. 2017 Jan;30(1):83-95. doi: 10.1111/tri.12878. Epub 2016 Nov 28.