Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F12%3A00056312" target="_blank" >RIV/00023001:_____/12:00056312 - isvavai.cz</a>

Výsledek na webu

<a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1432-2277.2012.01465.x/pdf" target="_blank" >http://onlinelibrary.wiley.com/doi/10.1111/j.1432-2277.2012.01465.x/pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/j.1432-2277.2012.01465.x" target="_blank" >10.1111/j.1432-2277.2012.01465.x</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation

Popis výsledku v původním jazyce

There is increasing interest in tacrolimus-minimization regimens. ASSET was an open-label, randomized, 12-month study of everolimus plus tacrolimus in de-novo renal-transplant recipients. Everolimus trough targets were 38 ng/ml throughout the study. Tacrolimus trough targets were 47 ng/ml during the first 3 months and 1.53 ng/ml (n = 107) or 47 ng/ml (n = 117) from Month 4. All patients received basiliximab induction and corticosteroids. The primary objective was to demonstrate superior estimated glomerular filtration rate (eGFR; MDRD-4) at Month 12 in the tacrolimus 1.53 ng/ml versus the 47 ng/ml group. Secondary endpoints included incidence of biopsy-proven acute rejection (BPAR; Months 412) and serious adverse events (SAEs; Months 012). Statisticalsignificance was not achieved for the primary endpoint (mean eGFR: 57.1 vs. 51.7 ml/min/1.73 m2), potentially due to overlapping of achieved tacrolimus exposure levels (Month 12 mean +/- SD, tacrolimus 1.53 ng/ml: 3.4 +/- 1.4; tacrolimus

Název v anglickém jazyce

Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation

Popis výsledku anglicky

There is increasing interest in tacrolimus-minimization regimens. ASSET was an open-label, randomized, 12-month study of everolimus plus tacrolimus in de-novo renal-transplant recipients. Everolimus trough targets were 38 ng/ml throughout the study. Tacrolimus trough targets were 47 ng/ml during the first 3 months and 1.53 ng/ml (n = 107) or 47 ng/ml (n = 117) from Month 4. All patients received basiliximab induction and corticosteroids. The primary objective was to demonstrate superior estimated glomerular filtration rate (eGFR; MDRD-4) at Month 12 in the tacrolimus 1.53 ng/ml versus the 47 ng/ml group. Secondary endpoints included incidence of biopsy-proven acute rejection (BPAR; Months 412) and serious adverse events (SAEs; Months 012). Statisticalsignificance was not achieved for the primary endpoint (mean eGFR: 57.1 vs. 51.7 ml/min/1.73 m2), potentially due to overlapping of achieved tacrolimus exposure levels (Month 12 mean +/- SD, tacrolimus 1.53 ng/ml: 3.4 +/- 1.4; tacrolimus

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FE - Ostatní obory vnitřního lékařství

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2012

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Transplant international

ISSN

0934-0874

e-ISSN

—

Svazek periodika

25

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

592-602

Kód UT WoS článku

000302475700016

EID výsledku v databázi Scopus

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