Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
Participant gender:
Summary
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5
additional years, or until the tablet formulation is commercially available (whichever occurs
first) in solid organ transplant recipients who are currently receiving sirolimus and who
have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To
evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets
administered for up to 5 years, or until the tablet formulation is commercially available in
solid organ transplant recipients who are currently receiving sirolimus and who have
completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled
in protocol 0468E1-306-US.