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

Roche

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation, Cytomegalovirus Infections

Treatments: Drug: valganciclovir [Valcyte]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01376804

2010-022514-47 (EudraCT Number)

NV25409

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 4 months to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Valganciclovir

Experimental group

Description:

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 \[7 \* Body Surface Area \* Creatinine Clearance\].

Treatment:

Drug: valganciclovir [Valcyte]