NCT07294547 Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study
| NCT ID | NCT07294547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Kidney Transplantation, Cytomegalovirus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-11-27 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07294547 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Kidney Transplantation, Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07294547 currently recruiting?
Yes, NCT07294547 is actively recruiting participants. Contact the research team at hxhuang@ntuh.gov.tw for enrollment information.
Where is the NCT07294547 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07294547 clinical trial?
NCT07294547 is sponsored by National Taiwan University Hospital. The trial plans to enroll 80 participants.
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