- Age > 18 years.
- End-stage renal disease with subjects scheduled to receive a primary or secondary
renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or
from a living-related mismatched donor. Unreported HLA values will be considered a
- Women of childbearing potential must have a negative serum pregnancy test before
administration of assigned treatment and agree to use a medically acceptable method of
contraception throughout the treatment period and for 3 months following
discontinuation of assigned treatment.
Other inclusions apply.
- Evidence of active systemic or localized major infection.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics,
corticosteroids, TAC or MMF.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs
other than renal transplant).
Other exclusions apply.