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

the ADHERE study investigators

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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
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Mycophenolic Acid
Tacrolimus
Sirolimus
Arm
Randomized Controlled Trials
Kidney
Transplant Recipients
Iohexol
Transplants
Graft Survival
Immunosuppressive Agents
Glomerular Filtration Rate
Creatinine
Adrenal Cortex Hormones

All Science Journal Classification (ASJC) codes

  • Transplantation

Cite this

@article{0e9bfc8fe2b14201a8efdc8ac30217e8,
title = "ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus",
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).",
author = "{the ADHERE study investigators} and Rummo, {Oleg O.} and Mario Carmellini and Lionel Rostaing and Rainer Oberbauer and Christiaans, {Maarten H.L.} and Christiane Mousson and Langer, {Robert M.} and Franco Citterio and Bernard Charpentier and Malcolm Brown and Gbenga Kazeem and Frank Lehner and Munish Heer and Wai Lim and Ferdinand M{\"u}hlbacher and Johann Pratschke and Cath{\'e}rine Bonvoisin and Dirk Kuypers and Jarmila Dedochova and Milan Kuman and {Le Meur}, Yann and Patrice Deteix and Luc Frimat and Philippe Lang and Yvon Lebranchu and Christophe Legendre and Westeel, {Pierre Francois} and Peter Schenker and Hilgers, {Karl Friedrich} and Oliver Witzke and Ingeborg Hauser and Volker Kliem and Martin Zeier and Ulrich Kunzendorf and Michael Bartels and Sven Jonas and Markus Guba and Wolters, {Heiner H.} and Chan, {Tak Mao} and Flavia Caputo and Vito Sparacino and Michal Nowicki and Maciej Glyda and Kim, {Yu Seun} and Jongwon Ha and Kim, {Chan Duck} and Han, {Duck Jong} and Kim, {Yeong Hoon} and Dmitry Perlin and Alexander Sal'mayer",
year = "2017",
month = "1",
day = "1",
doi = "10.1111/tri.12878",
language = "English",
volume = "30",
pages = "83--95",
journal = "Transplant International",
issn = "0934-0874",
publisher = "Wiley-Blackwell",
number = "1",

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TY - JOUR

T1 - ADHERE

T2 - randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus

AU - the ADHERE study investigators

AU - Rummo, Oleg O.

AU - Carmellini, Mario

AU - Rostaing, Lionel

AU - Oberbauer, Rainer

AU - Christiaans, Maarten H.L.

AU - Mousson, Christiane

AU - Langer, Robert M.

AU - Citterio, Franco

AU - Charpentier, Bernard

AU - Brown, Malcolm

AU - Kazeem, Gbenga

AU - Lehner, Frank

AU - Heer, Munish

AU - Lim, Wai

AU - Mühlbacher, Ferdinand

AU - Pratschke, Johann

AU - Bonvoisin, Cathérine

AU - Kuypers, Dirk

AU - Dedochova, Jarmila

AU - Kuman, Milan

AU - Le Meur, Yann

AU - Deteix, Patrice

AU - Frimat, Luc

AU - Lang, Philippe

AU - Lebranchu, Yvon

AU - Legendre, Christophe

AU - Westeel, Pierre Francois

AU - Schenker, Peter

AU - Hilgers, Karl Friedrich

AU - Witzke, Oliver

AU - Hauser, Ingeborg

AU - Kliem, Volker

AU - Zeier, Martin

AU - Kunzendorf, Ulrich

AU - Bartels, Michael

AU - Jonas, Sven

AU - Guba, Markus

AU - Wolters, Heiner H.

AU - Chan, Tak Mao

AU - Caputo, Flavia

AU - Sparacino, Vito

AU - Nowicki, Michal

AU - Glyda, Maciej

AU - Kim, Yu Seun

AU - Ha, Jongwon

AU - Kim, Chan Duck

AU - Han, Duck Jong

AU - Kim, Yeong Hoon

AU - Perlin, Dmitry

AU - Sal'mayer, Alexander

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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).

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 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).

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U2 - 10.1111/tri.12878

DO - 10.1111/tri.12878

M3 - Article

C2 - 27754567

AN - SCOPUS:85005915305

VL - 30

SP - 83

EP - 95

JO - Transplant International

JF - Transplant International

SN - 0934-0874

IS - 1

ER -