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NCT07294547Recruiting

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.

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
8 Dec 2025
Start date
Nov 2025
Primary completion date
Dec 2029
Lead sponsor
National Taiwan University Hospital
NCT number
NCT07294547

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From Nov 2025 to the primary completion date, Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe co-morbidities that would preclude safe participation as judged by the transplant surgeon

Other illness

  • Known allergy to both valacyclovir and valganciclovir

Other

  • Pregnancy (valganciclovir is likely teratogenic)

Who the study is looking for

  • 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.

Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.