A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

Inclusion Criteria:

• Children, 4 months to 16 years of age
• Patient has received a kidney transplant
• At risk of developing cytomegalovirus disease
• Adequate hematological and renal function
• Able to tolerate oral medication
• Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

• Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
• Severe uncontrolled diarrhea (more than 5 watery stools per day)
• Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]
• Patient requires use of any protocol prohibited concomitant medication
• Previous participation in this clinical study