Conditions: Cytomegalovirus Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Valganciclovir for up to 100 days post kidney transplant arm 2: Valganciclovir for up to 200 days post kidney transplant

Interventions: intervention 1: Valganciclovir intervention 2: Valganciclovir
Intervention descriptions: intervention 1: 900 mg orally daily for up to 100 days intervention 2: 900 mg orally daily for up to 200 days

Protocol document: