Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F10%3A00002429" target="_blank" >RIV/00023001:_____/10:00002429 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1038/ki.2009.506" target="_blank" >http://dx.doi.org/10.1038/ki.2009.506</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1038/ki.2009.506" target="_blank" >10.1038/ki.2009.506</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial

Popis výsledku v původním jazyce

The cost of immunosuppression following transplantation can be reduced by using generic ciclosporin (for example, Equoral) rather than innovator ciclosporin drugs such as Neoral. Thus, this study aims to evaluate the interchangeability, safety, and tolerability of Equoral, a generic ciclosporin, with Neoral in stable adult renal transplant recipients. This was a multicenter, randomized, open-label, parallel-group clinical trial in stable renal transplant patients, comparing 6 months of treatment with Equoral with the same treatment period on Neoral. The primary end point was the between-treatment comparison of the total daily ciclosporin dose at the end of the study. A total of 99 patients were enrolled and constituted the full analysis/safety population, and 78 patients forming the per-protocol population were assessed for efficacy. Equoral was found to be equivalent to Neoral with regard to the primary end point of daily dose at the end of the study. This was supported by comparable

Název v anglickém jazyce

Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial

Popis výsledku anglicky

The cost of immunosuppression following transplantation can be reduced by using generic ciclosporin (for example, Equoral) rather than innovator ciclosporin drugs such as Neoral. Thus, this study aims to evaluate the interchangeability, safety, and tolerability of Equoral, a generic ciclosporin, with Neoral in stable adult renal transplant recipients. This was a multicenter, randomized, open-label, parallel-group clinical trial in stable renal transplant patients, comparing 6 months of treatment with Equoral with the same treatment period on Neoral. The primary end point was the between-treatment comparison of the total daily ciclosporin dose at the end of the study. A total of 99 patients were enrolled and constituted the full analysis/safety population, and 78 patients forming the per-protocol population were assessed for efficacy. Equoral was found to be equivalent to Neoral with regard to the primary end point of daily dose at the end of the study. This was supported by comparable

Druh

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

CEP obor

FJ - Chirurgie včetně transplantologie

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2010

Kód důvěrnosti údajů

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

Název periodika

Kidney International

ISSN

0085-2538

e-ISSN

—

Svazek periodika

77

Číslo periodika v rámci svazku

suppl. 115

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

5

Strana od-do

"S12"-"S16"

Kód UT WoS článku

000274445800003

EID výsledku v databázi Scopus

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