IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

• Status: Completed
• Trial end date: 2009-08-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• ≥ 16 years of age

• CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor

• Adequate hematological and renal function

• Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication

Exclusion Criteria:

• CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening

• Multi-organ transplant recipient

• Hepatitis B, hepatitis C or HIV positive

• Women who are pregnant or lactating