A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Inclusion Criteria:
Exclusion Criteria:
San Francisco, California 94143-0116, United States
Chicago, Illinois 60612-3824, United States
Indianapolis, Indiana 46202-5124, United States
Boston, Massachusetts 02111, United States
Winston-Salem, North Carolina 27157-1082, United States
Philadelphia, Pennsylvania 19102-1192, United States
San Antonio, Texas 78284, United States
Seattle, Washington 98195, United States
Berlin, 13353, Germany
Erlangen, 91054, Germany
Hanover, 30625, Germany
Lübeck, 23562, Germany
Rome, Lazio 00168, Italy
Milan, Lombardy 20162, Italy
Krakow, 31-501, Poland
Warsaw, 02-006, Poland
Wroclaw, 50-417, Poland
L'Hospitalet de Llobregat, Barcelona 08907, Spain