- Age: = to ≥ 18 years.
- End-stage renal disease, with patients scheduled to receive a primary or secondary
renal allograft from a cadaveric donor, from a living-unrelated donor, or from a
- Patients with second and subsequent transplants must have maintained their primary
graft for at least 6 months after transplantation (with the exception of graft failure
due to technical reasons).
- Evidence of active systemic or localised major infection prior to initial Rapamune®
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the
study and during the 12-month treatment phase. Exception: the use of erythropoiesis
stimulating products. In these cases, erythrocyte-stimulating products must be
discontinued prior to administration of Rapamune®.