Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study
Non-Inferiority Assessment of Valacyclovir Versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients: A Single-Center Prospective Randomized Pilot Study.
National Taiwan University Hospital
80 participants
Nov 27, 2025
INTERVENTIONAL
Conditions
Summary
Opportunistic CMV viremia (primary infection or reactivation) is usually managed by taking prophylactic medication for both adult and pediatric kidney transplant patients. Most hospitals prescribe valganciclovir for this purpose but valacyclovir has also been used. The most unfavorable side effect of valganciclovir is bone marrow suppression which can be troublesome for kidney transplant patients who are already immunosuppressed. We aim to assess the non-inferiority of valacyclovir compared with valganciclovir in this study.
Eligibility
Inclusion Criteria5
- Age at least 3 years of age
- Patients who are about to receive or just received kidney transplantation within the past 2 weeks before the date of screening.
- Will be receiving prophylactic antiviral therapy against CMV and/or EBV per discretion of transplant surgeon
- No active CMV or EBV viremia (as defined by detectable viral load PCR) at the time of screening.
- Ability and willingness of the patient (or parent/legal guardian for minors) to provide informed consent and comply with study procedures.
Exclusion Criteria3
- Severe co-morbidities that would preclude safe participation as judged by the transplant surgeon
- Pregnancy (valganciclovir is likely teratogenic)
- Known allergy to both valacyclovir and valganciclovir
Interventions
Standard adult dose will be 1000 mg orally twice daily. For pediatric patients, dosing will be weight-based 20 mg/kg/dose twice daily; maximum dose: 1000 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.
Dosing: Standard adult dose will be 450 mg orally once daily. For pediatric patients, dosing will be weight-based 15 mg/kg/dose once daily; maximum dose: 450 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines. For pediatric patients who could not swallow pills, Valcyte also comes in the form of suspension (prepared by National Taiwan University Hospital in-house pharmacy).
Locations(1)
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NCT07294547