You are here

Our science / Clinical Trials / Find a Trial / NCT00086346

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

Back to Search Print Save as PDF Bookmark Trial

NCT00086346

Last updated on May 12, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
San Francisco, California, 94143-0780 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882
All Genders
18+
Years
Multiple Sites
Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
2-Week Study In People With Nonalcoholic Fatty Liver Disease
NCT03513588
All Genders
18+
Years
Multiple Sites
Non-alcoholic Fatty Liver Disease
6-week Safety and PD Study in Adults With NAFLD
NCT03256526
All Genders
18+
Years
Multiple Sites
Non-alcoholic Fatty Liver Disease
Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects
NCT02974374
All Genders
18+
Years
New Haven, Connecticut
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, tri[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

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]



Call Now