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Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Los Angeles, California, 90057 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Graft vs Host Disease, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- Signed and dated informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Unstable disease states, which in the opinion of the investigator would present a risk
to the patient.

- Known hypersensitivity to macrolide antibiotics

NCT00037531
Pfizer
Completed
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

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Study Evaluating Sirolimus (Rapamune?) in Solid Organ Transplant Recipients
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune?) in Solid Organ Transplant Recipients
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.
Not Provided
Interventional
Phase 3
Not Provided
  • Graft vs Host Disease
  • Kidney Transplantation
Drug: Sirolimus (RAPAMUNE)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
769
August 2004
August 2004   (Final data collection date for primary outcome measure)

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.
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00037531
0468E1-306
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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