- Age is older than 18 years.
- End-stage renal disease, with subjects scheduled for kidney transplant.
- Women of childbearing potential must not be pregnant and agree to medically acceptable
method of contraception throughout the treatment period and for 3 months following
discontinuation of assigned treatment.
Other inclusion applies.
- Evidence of active systemic or localized major infection.
- Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics,
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs
other than renal transplant).
- Immunosuppression therapies other than those allowed in the protocol.
- Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or
ketoconazole (all known to interact with SRL) that is not discontinued prior to study
Other exclusion applies.