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

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.
 
ClinicalTrials.gov Identifier: NCT00086346
Recruitment Status : Terminated
First Posted : July 2, 2004
Results First Posted : September 7, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Liver Transplantation Drug: Sirolimus (Rapamune) Drug: Cyclosporine or Tacrolimus Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 607 participants
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
Study Start Date : December 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Active Comparator: A Drug: Sirolimus (Rapamune)
Active Comparator: B Drug: Cyclosporine or Tacrolimus



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Number of Patients With a Biopsy Confirmed Acute Rejection [ Time Frame: 12 months ]
    Overall event rate is determined as yes or no.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
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.

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


Locations
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United States, California
San Francisco, California, United States, 94143-0780
United States, Florida
Tampa, Florida, United States, 33606
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
Omaha, Nebraska, United States, 68198-3285
United States, New York
New York, New York, United States, 10029
Rochester, New York, United States, 14642-8410
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Belgium
Gent, Belgium, 9000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Toronto, Ontario, Canada, M5G 2C4
Czech Republic
Prague, Czech Republic, 14021
France
Clichy, France, 92118
Lyon, France, 69437
Nice, France, 06200
Paris, France, 75679
Rennes, France, 35033
Villejuif, France, 94800
Germany
Berlin, Germany, 13353
Hamburg, Germany, 20251
München, Germany, 81377
Italy
Bologna, Italy
Milano, Italy, 20122
Padova, Italy, 35128
Netherlands
Leiden, Netherlands, 2300
Portugal
Coimbra, Portugal, 3049
Lisboa, Portugal, 1069-166
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Madrid, Spain, 28034
Pamplona, Spain, 31008
Santiago de Compostela, Spain, 15706
Valencia, Spain, 46009
Switzerland
Bern, Switzerland, CH-3010
Zürich, Switzerland, CH-8091
United Kingdom
Birmingham, United Kingdom, B15 2TH
Edinburgh, United Kingdom, EH16 4SA
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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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

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00086346    
Other Study ID Numbers: 0468H1-313
First Posted: July 2, 2004    Key Record Dates
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:
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Cyclosporine
Sirolimus
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents