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Study to compare a tacrolimus Hexal® based regimen versus a Prograf® based regimen in renal transplantation

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-003795-36

Femme et Homme

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  • | Spécialités :
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Extrait

PHASE I: To demonstrate that the pharmacokinetics of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over a one month period post-transplantation is comparable to Prograf® in renal transplant patients. PHASE II (including the patients enrolled in Phase I, Phase II study will not be conducted): To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) between both treatment arms at month 6 post-transplantation in renal transplant patients.

Critère d'inclusion

  • renal transplantation

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