Clinical trial NCT00086346: Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Liver
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-07-02
Enrollment: 607
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
timeFrame: Baseline and 12 months
measure: Patient and Graft Survival
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients With a Biopsy Confirmed Acute Rejection
timeFrame: 12 months
measure: Mean Serum Creatinine
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Gent
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Prague
country: Czech Republic
city: Clichy
country: France
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Rennes
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: München
country: Germany
city: Bologna
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Leiden
country: Netherlands
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Santiago de Compostela
country: Spain
city: Valencia
country: Spain
city: Bern
country: Switzerland
city: Zürich
country: Switzerland
city: Birmingham
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Leeds
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Italy, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Czech Republic, WPPGCLI@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: