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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FJ - Surgery including transplantology

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2010

Confidentiality

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

Name of the periodical

Kidney International

ISSN

0085-2538

e-ISSN

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Volume of the periodical

77

Issue of the periodical within the volume

suppl. 115

Country of publishing house

US - UNITED STATES

Number of pages

5

Pages from-to

"S12"-"S16"

UT code for WoS article

000274445800003

EID of the result in the Scopus database

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