[HTML][HTML] A randomized, multicenter study of steroid avoidance, early steroid withdrawal or standard steroid therapy in kidney transplant recipients
F Vincenti, FP Schena, S Paraskevas, IA Hauser… - American journal of …, 2008 - Elsevier
In a randomized, open-label, multicenter study, de novo renal transplant patients received
no steroids (n= 112), steroids to day 7 (n= 115), or standard steroids (n= 109) with
cyclosporine microemulsion (CsA-ME), enteric-coated mycophenolate sodium (EC-MPS)
and basiliximab. The primary objective, to demonstrate noninferiority of 12-month GFR in the
steroid-free or steroid-withdrawal groups versus standard steroids, was not met in the intent-
to-treat population. However, investigational groups were not inferior to standard steroids in …
no steroids (n= 112), steroids to day 7 (n= 115), or standard steroids (n= 109) with
cyclosporine microemulsion (CsA-ME), enteric-coated mycophenolate sodium (EC-MPS)
and basiliximab. The primary objective, to demonstrate noninferiority of 12-month GFR in the
steroid-free or steroid-withdrawal groups versus standard steroids, was not met in the intent-
to-treat population. However, investigational groups were not inferior to standard steroids in …