254
Participants
Start Date
June 30, 2009
Primary Completion Date
August 31, 2013
Study Completion Date
August 31, 2013
Tacrolimus
During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days).
Sirolimus
Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months).
Tacrolimus
During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.
Pfizer Investigational Site, Randwick
Pfizer Investigational Site, Adelaide
Pfizer Investigational Site, Nedlands
Pfizer Investigational Site, New York
Pfizer Investigational Site, Berlin
Pfizer Investigational Site, Rochester
Pfizer Investigational Site, Philadelphia
Pfizer Investigational Site, Milan
Pfizer Investigational Site, Milan
Pfizer Investigational Site, Charlottesville
Pfizer Investigational Site, Charlottesville
Pfizer Investigational Site, Richmond
Pfizer Investigational Site, Durham
Pfizer Investigational Site, Madrid
Pfizer Investigational Site, Madrid
Pfizer Investigational Site, Charleston
Pfizer Investigational Site, Atlanta
Pfizer Investigational Site, Santander
Pfizer Investigational Site, Lexington
Pfizer Investigational Site, Cleveland
Pfizer Investigational Site, Valencia
Pfizer Investigational Site, Detroit
Pfizer Investigational Site, Detroit
Pfizer Investigational Site, Chicago
Pfizer Investigational Site, Houston
Pfizer Investigational Site, Aurora
Pfizer Investigational Site, Denver
Pfizer Investigational Site, La Jolla
Pfizer Investigational Site, San Francisco
Pfizer Investigational Site, Portland
Pfizer Investigational Site, Portland
Pfizer Investigational Site, Boston
Pfizer Investigational Site, Chapel Hill
Pfizer Investigational Site, Cincinnati
Pfizer Investigational Site, Cincinnati
Pfizer Investigational Site, Ciudad de Buenos Aires
Pfizer Investigational Site, Porto Alegre
Pfizer Investigational Site, Bela Vista
Pfizer Investigational Site, São Paulo
Pfizer Investigational Site, São Paulo
Pfizer Investigational Site, São Paulo
Pfizer Investigational Site, São Paulo
Pfizer Investigational Site, Barcelona
Pfizer Investigational Site, Barcelona
Lead Sponsor
Pfizer
INDUSTRY