RecruitingNot ApplicableNCT07294547

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.

Sponsor

National Taiwan University Hospital

Enrollment

80 participants

Start Date

Nov 27, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Transplantation, Cytomegalovirus Infections EBV Infection Antiviral Prophylaxis

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

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This study compares two antiviral medications — valacyclovir and valganciclovir — to see if valacyclovir works just as well at preventing two common viral infections (CMV and EBV) in kidney transplant patients. **You may be eligible if...** - You are at least 3 years old - You recently had or are about to have a kidney transplant (within the past 2 weeks) - Your transplant doctor plans to give you antiviral prevention medication - You do not currently have an active CMV or EBV infection **You may NOT be eligible if...** - You have serious health conditions that make participation unsafe - You are pregnant (one of the study drugs can harm a developing baby) - You have a known allergy to both valacyclovir and valganciclovir Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGValacyclovir (Valtrex)

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.

DRUGValganciclovir (Valcyte)

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).