RecruitingNot Applicable

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

Taiwan80 participantsStarted 2025-11-27

Plain-language 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.

Who can participate

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Time to new-onset CMV viremia

Timeframe: up to 2 years

Time to new-onset EBV viremia

Timeframe: up to 2 years

Cumulative incidence of new-onset CMV viremia

Timeframe: 6 months, 1year, and 2 years

Cumulative incidence of new-onset EBV viremia

Timeframe: 6 months, 1 year, and 2 years

Trial details

NCT IDNCT07294547

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Hou-Xuan Huang, MD

886-2312-3456 hxhuang@ntuh.gov.tw