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.

Condition	Treatment or Intervention	Phase
Organ Transplantation	Drug: Sirolimus (RAPAMUNE)	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Completion of sirolimus/blinded therapy in solid organ clinical trials (with or without CsA) with satisfactory compliance and an adequate safety profile.
• Women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study. (Any woman becoming pregnant during the 5-year treatment period will discontinue sirolimus).
• Signed and dated informed consent

Exclusion Criteria:

• Unstable disease states, which in the opinion of the investigator would present a risk to the patient.
• Known hypersensitivity to macrolide antibiotics

California
      National Institute Of Transplantation, Los Angeles,  California,  90057,  United States
      Sharp Memorial Hospital, San Diego,  California,  92123,  United States
      Stanford University Medical Center, Stanford,  California,  94304,  United States
      UCLA Medical Center, Los Angeles,  California,  90095-1752,  United States
Florida
      Life Link Transplant Institute, Tampa,  Florida,  33606,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      University of Chicago Medical Center, Chicago,  Illinois,  60637,  United States
Indiana
      Clarion Health Partners Indiana University Medical Center, Indianapolis,  Indiana,  46202-5250,  United States
New York
      Mount Sinai Hemophilia Center, New York,  New York,  10029,  United States
North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28232,  United States
Pennsylvania
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19141,  United States
      University of Pittsburgh School of Medicine, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Medical University Of South Carolina, Charleston,  South Carolina,  29425-0777,  United States
Canada, Alberta
      University of Alberta Hospital, Edmonton,  Alberta,  T6G 2B7,  Canada
Canada, British Columbia
      Vancouver General Hospital, Vancouver,  British Columbia,  V5Z 1M9,  Canada
Canada, Nova Scotia
      Queen Elizabeth II Health Science Center, Halifax,  Nova Scotia,  B3H 2Y9,  Canada
Canada, Ontario
      The Toronto Hospital, Toronto,  Ontario,  M5G 2C4,  Canada
      St. Michael's Hospital, Toronto,  Ontario,  M5B 1W8,  Canada
Canada, Quebec
      C.H.U.M. Hospital Notre-Dame, Montreal,  Quebec,  H2L 2W5,  Canada

Study ID Numbers:  0468E1-306-US
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  May 17, 2002
ClinicalTrials.gov Identifier:  NCT00037531
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08