A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-001984-31

A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS

Femme et Homme

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Extrait

1) To compare the incidence of clinical biopsy-proven acute rejection (BPAR) (as interpreted by the central blinded pathologist) of combination regimens of CP-90,550 and mycophenolate mofetil (MMF) / mycophenolate sodium (MPS) versus a cyclosporine (CsA)-based regimen in recipients of first renal allografts at Month 6 posttransplant 2) To compare glomerular filtration rate (GFR), as measured by iohexol serum clearance, of combination regimens of CP-690,550 and MMF/MPS versus a CsA-based regimen at Month 12 posttransplant


Critère d'inclusion

  • Prevention of kidney allograft rejection