Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplantation; Graft vs Host Disease
Intervention: Sirolimus (Rapamune) (Drug); Cyclosporine or Tacrolimus (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Italy, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, MedInfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Czech Republic, WPPGCLI@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK, ukmedinfo@wyeth.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in calculated glomerular filtration rate at 12 months.First occurence of graft loss or death at 12 months
Secondary outcome: Incidence of biopsy confirmed acute rejection at 2, 6, 12, 24, 36, 48, 60 and 72 months.Subject and graft survival at 12, 24, 36, 48, 60 and 72 months. Change from baseline in creatinine at 6, 12, 24, 36, 48, 60 and 72 months
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Exclusion Criteria:
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy < 5 years before random assignment.
Locations and Contacts
Gent 9000, Belgium
Prague 14021, Czech Republic
Clichy 92118, France
Lyon 69437, France
Rennes 35033, France
Paris 75679, France
Villejuif 94800, France
Nice 06200, France
Berlin 13353, Germany
München 81377, Germany
Hamburg 20251, Germany
Bologna, Italy
Milano 20122, Italy
Padova 35128, Italy
Leiden 2300, Netherlands
Coimbra 3049, Portugal
Lisboa 1069-166, Portugal
Valencia 46009, Spain
Barcelona 08035, Spain
Barcelona 08907, Spain
Santiago de Compostela 15706, Spain
Barcelona 08036, Spain
Pamplona 31008, Spain
Madrid 28034, Spain
Zürich CH-8091, Switzerland
Bern CH-3010, Switzerland
Leeds LS9 7TF, United Kingdom
Edinburgh EH16 4SA, United Kingdom
Birmingham B15 2TH, United Kingdom
Edmonton, Alberta T6G 2B7, Canada
San Francisco, California 94143-0780, United States
Tampa, Florida 33606, United States
New Orleans, Louisiana 70121, United States
Detroit, Michigan 48202, United States
Rochester, Minnesota 55905, United States
Omaha, Nebraska 68198-3285, United States
New York, New York 10029, United States
Rochester, New York 14642-8410, United States
Cleveland, Ohio 44195, United States
London, Ontario N6A 5A5, Canada
Toronto, Ontario M5G 2C4, Canada
Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: December 2002
Ending date: December 2012
Last updated: December 19, 2007
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