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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

Criteria

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.