A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• primary or secondary renal allograft within preceding 14 days;
• IgG seropositive for CMV;
• receiving immunosuppressive therapy.

Exclusion Criteria:

• active CMV infection;
• current/history of malignancy;
• acute steroid resistant rejection episode since transplantation.