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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00086346 |
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Date of registration:
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30/06/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
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Scientific title:
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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 |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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607 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00086346 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Italy
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Netherlands
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Portugal
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For UK, ukmedinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedInfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Czech Republic, WPPGCLI@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, decresg@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Switzerland, med@wyeth.com |
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Key inclusion & exclusion criteria
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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.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Transplantation
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Intervention(s)
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Drug: Sirolimus (Rapamune)
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Drug: Cyclosporine or Tacrolimus
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Primary Outcome(s)
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Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
[Time Frame: Baseline and 12 months]
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Patient and Graft Survival
[Time Frame: 12 months]
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Secondary Outcome(s)
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Mean Serum Creatinine
[Time Frame: 12 months]
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Number of Patients With a Biopsy Confirmed Acute Rejection
[Time Frame: 12 months]
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Secondary ID(s)
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0468H1-313
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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