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

RecruitingNAAges 3 Years - anyAllNational Taiwan University Hospital
NCT07294547 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Valacyclovir (Valtrex)
  • Valganciclovir (Valcyte)
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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