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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086346
First Posted: July 2, 2004
Last Update Posted: April 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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.

Condition Intervention Phase
Liver Transplantation Drug: Sirolimus (Rapamune) Drug: Cyclosporine or Tacrolimus Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and 12 months ]
    GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.

  • Patient and Graft Survival [ Time Frame: 12 months ]
    Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.


Secondary Outcome Measures:
  • Number of Patients With a Biopsy Confirmed Acute Rejection [ Time Frame: 12 months ]
    Overall event rate is determined as yes or no.

  • Mean Serum Creatinine [ Time Frame: 12 months ]
    Observed mean values for serum creatinine.


Enrollment: 607
Study Start Date: December 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Sirolimus (Rapamune)
Active Comparator: B Drug: Cyclosporine or Tacrolimus

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086346


  Show 42 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedinfo@wyeth.com
  More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00086346     History of Changes
Other Study ID Numbers: 0468H1-313
First Submitted: June 30, 2004
First Posted: July 2, 2004
Results First Submitted: July 6, 2009
Results First Posted: September 7, 2009
Last Update Posted: April 28, 2010
Last Verified: April 2010

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Liver
Transplant

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents