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Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
San Francisco, California, 94143-0780 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liver Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age greater than 13 years (age greater than 18 years as required by some local
regulations).

- Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/-
corticosteroids +/- antimetabolite.

- 6 to 144 months after orthotopic liver transplantation.

- Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

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

- History of nonhepatic transplantation

- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).

- Known or suspected malignancy

NCT00086346
Pfizer
Terminated
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

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Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Transplantation
  • Drug: Sirolimus (Rapamune)
  • Drug: Cyclosporine or Tacrolimus
  • Active Comparator: A
    Intervention: Drug: Sirolimus (Rapamune)
  • Active Comparator: B
    Intervention: Drug: Cyclosporine or Tacrolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
607
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than 13 years (age greater than 18 years as required by some local regulations).
  • Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
  • 6 to 144 months after orthotopic liver transplantation.
  • Cockcroft-Gault GFR values ?40 mL/min and ?90mL/min at screening

Exclusion Criteria:

  • History of nonhepatic transplantation
  • Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
  • Known or suspected malignancy < 5 years before random assignment.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   Switzerland,   United Kingdom,   United States
 
 
NCT00086346
0468H1-313
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Czech Republic, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Switzerland, [email protected]
Principal Investigator: Trial Manager For UK, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

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

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