Valacyclovir versus valganciclovir to prevent CMV and EBV after kidney transplant
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.
NA · National Taiwan University Hospital · NCT07294547
This test checks whether valacyclovir works as well as valganciclovir to prevent CMV and EBV in people who recently had a kidney transplant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07294547 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, randomized non-inferiority pilot compares valacyclovir and valganciclovir as antiviral prophylaxis in kidney transplant recipients. Eligible participants (age ≥3) are enrolled within two weeks of transplantation if they have no detectable CMV or EBV viremia and are randomized to receive one of the two antiviral regimens. Follow-up includes regular viral load surveillance for CMV and EBV and safety monitoring for hematologic and renal adverse effects. The study aims to compare the incidence of post-transplant CMV and EBV viremia and record tolerability and adverse events between the two drugs.
Who should consider this trial
Good fit: Ideal candidates are kidney transplant recipients age 3 or older within two weeks of transplantation who have no detectable CMV or EBV viremia at screening and can provide consent and attend follow-up at the study site.
Not a fit: Patients with active CMV or EBV viremia at screening, pregnant patients, those with severe comorbidities that preclude safe participation, or those allergic to both medications are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, this could provide a less toxic and lower-cost option for CMV/EBV prevention with reduced risk of bone marrow suppression.
How similar studies have performed: Some retrospective studies suggest valacyclovir may perform comparably to valganciclovir for CMV prophylaxis, but prospective randomized evidence is limited, so the approach is partly supported but not well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hou-Xuan Huang, MD
- Email: hxhuang@ntuh.gov.tw
- Phone: 886-2312-3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Transplantation, Cytomegalovirus Infections, EBV Infection, Antiviral Prophylaxis, Non-Inferiority Assessment of Valacyclovir versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients