Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Public ClinicalTrials.gov record NCT00037531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00037531
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 769 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Aug 2004 (Actual)
- Completion
- Aug 2004 (Actual)
- Last update posted
- Aug 18, 2009
Ends 2004
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Los Angeles | California | 90095-1752 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Stanford | California | 94304 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Augusta | Georgia | 30912 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Indianapolis | Indiana | 46202-5250 | — |
| Not listed | New York | New York | 10029 | — |
| Not listed | Charlotte | North Carolina | 28232 | — |
| Not listed | Philadelphia | Pennsylvania | 19141 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Charleston | South Carolina | 29425-0777 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00037531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2009 · Synced Nov 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00037531 live on ClinicalTrials.gov.