Mobile

A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0 g MMF with sta...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-003413-32

A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0 g MMF with standard dose Neoral in de novo heart transplant recipients

Femme et Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

To assess if comparable rates of the composite efficacy failure (biopsy-proven acute rejection of ISHLT grade ≥ 3A, acute rejection episodes associated with hemodynamic compromise, graft loss/re-transplant, death, or loss to follow-up) are achieved in cohorts of de novo heart recipients treated with Certican-reduced Neoral versus MMF-Neoral standard dose at 12 months after initial dose of study medication

Critère d'inclusion

  • de novo heart transplantation

Liens