Conditions: Kidney Transplantation, Cytomegalovirus Infections
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm \[7 \* Body Surface Area \* Creatinine Clearance\].

Interventions: intervention 1: valganciclovir [Valcyte]
Intervention descriptions: intervention 1: Oral, daily for up to 200 days.

Protocol document: