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| Description
| - 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). Statistical significance 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 47 ng/ml: 5.5 +/- 2.0 ng/ml). BPAR (months 412) and SAE rates were comparable between groups (2.7% vs. 1.1% and 58.7% vs. 51.3%; respectively). Everolimus-facilitated tacrolimus minimization, to levels lower than previously investigated, achieved good renal function, low BPAR and graft-loss rates, and an acceptable safety profile in renal transplantation over 12 months although statistically superior renal function of the 1.53 ng/ml tacrolimus group was not achieved.
- 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). Statistical significance 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 47 ng/ml: 5.5 +/- 2.0 ng/ml). BPAR (months 412) and SAE rates were comparable between groups (2.7% vs. 1.1% and 58.7% vs. 51.3%; respectively). Everolimus-facilitated tacrolimus minimization, to levels lower than previously investigated, achieved good renal function, low BPAR and graft-loss rates, and an acceptable safety profile in renal transplantation over 12 months although statistically superior renal function of the 1.53 ng/ml tacrolimus group was not achieved. (en)
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| Title
| - Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation
- Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation (en)
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| skos:prefLabel
| - Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation
- Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation (en)
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| skos:notation
| - RIV/00023001:_____/12:00056312!RIV13-MZ0-00023001
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| http://linked.open...avai/riv/aktivita
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| http://linked.open...avai/riv/aktivity
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| http://linked.open...iv/cisloPeriodika
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| http://linked.open...vai/riv/dodaniDat
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| http://linked.open...aciTvurceVysledku
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| http://linked.open.../riv/druhVysledku
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| http://linked.open...iv/duvernostUdaju
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| http://linked.open...titaPredkladatele
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| http://linked.open...dnocenehoVysledku
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| http://linked.open...ai/riv/idVysledku
| - RIV/00023001:_____/12:00056312
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| http://linked.open...riv/jazykVysledku
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| http://linked.open.../riv/klicovaSlova
| - tacrolimus; proliferation signal inhibitors; mammalian target of rapamycin inhibitor; everolimus; calcineurin inhibitor minimization (en)
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| http://linked.open.../riv/klicoveSlovo
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| http://linked.open...odStatuVydavatele
| - GB - Spojené království Velké Británie a Severního Irska
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| http://linked.open...ontrolniKodProRIV
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| http://linked.open...i/riv/nazevZdroje
| |
| http://linked.open...in/vavai/riv/obor
| |
| http://linked.open...ichTvurcuVysledku
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| http://linked.open...cetTvurcuVysledku
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| http://linked.open...UplatneniVysledku
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| http://linked.open...v/svazekPeriodika
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| http://linked.open...iv/tvurceVysledku
| - Rostaing, Lionel
- Vítko, Štefan
- Cassuto, Elisabeth
- Christiaans, Maarten
- Ciechanowski, Kazimierz
- Dong, Gaohong
- Hene, Ronald
- Junge, Guido
- Langer, Robert M
- Machein, Uwe
- Pascual, Julio
- Tedesco-Silva, Helio
- Ulbricht, Bettina
- Vilatoba, Mario
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| http://linked.open...ain/vavai/riv/wos
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| issn
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| number of pages
| |
| http://bibframe.org/vocab/doi
| - 10.1111/j.1432-2277.2012.01465.x
|
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