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

December 8, 2025 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CMV viremia and EBV viremia are commonly seen in immunosuppressed kidney transplant recipients. These patients are at highest risk for CMV or EBV viremia early post-transplant or during a period of heightened immunosuppressive regimen to treat acute rejection. CMV viremia could be asymptomatic when the viral load is low, but if uncontrolled, it could lead to severe organ-invasive disease. On the other hand, EBV viremia, though usually not an immediate threat to allograft, harbors risk for post-transplant lymphoproliferative disease (PTLD).Therefore, most transplant centers adopt regular surveillance as well as following certain protocols of antiviral prophylaxis, using valganciclovir specifically against CMV viremia.

Valganciclovir is highly effective as prophylaxis for CMV viremia, but it is also known for its side effects such as myelosuppression and nephrotoxicity. Valacyclovir, though better known for its therapeutic effect for herpes simplex virus, is emerging as an alternative to valganciclovir since some retrospective studies showing its comparative efficacy in CMV prophylaxis. Valacyclovir has favorable side effect profile, and is less expensive. It may also reduce EBV viral shedding in oropharynx, though there's no evidence showing its efficacy in preventing EBV viremia or even PTLD in kidney transplant patients. Given that there are scarce prospective studies comparing these two medications in kidney transplant recipients, our study aims to assess the non-inferiority of valacyclovir compared with valganciclovir as prophylaxis for CMV viremia and investigate its non-inferiority for EBV viremia. We will include both pediatric and adult kidney transplant recipients who received kidney transplant less than 5 years prior to study participation and the patients will be stratified based on their age, years post-transplant, and CMV risk status. Serum viral load and other possible side effects will be monitored during their clinic visits for at least 2 years. The findings from this study will be informative for the design and power calculations for a larger multicenter non-inferiority trial. If valacyclovir is indeed non-inferior to valgancyclovir in both CMV viremia and EBV viremia, utilizing this medication in our post-kidney transplant protocol may help reduce side effect burden and potentially save substantial healthcare cost.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Sub-Investigator:
          • Yi-Jen Huang, PharmD
        • Principal Investigator:
          • Hou-Xuan Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group (Valacyclovir)

Standard adult dose for Valacyclovir will be 1000 mg orally twice daily. For pediatric patients, dosing will be weight-based 20 mg/kg/dose twice daily; maximum dose: 1000 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.

Patients will continue their assigned prophylactic regimen for at least 6 months.
Drug: Valacyclovir (Valtrex)

Standard adult dose will be 1000 mg orally twice daily. For pediatric patients, dosing will be weight-based 20 mg/kg/dose twice daily; maximum dose: 1000 mg/dose.

The exact dosage will be adjusted for renal function based on published guidelines.
Active Comparator: Control group (Valganciclovir)

Standard adult dose for Valganciclovir will be 450 mg orally once daily. For pediatric patients, dosing will be weight-based 15 mg/kg/dose once daily; maximum dose: 450 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.

For pediatric patients who could not swallow pills, Valganciclovir also comes in the form of suspension (prepared by National Taiwan University Hospital in-house pharmacy).

Patients will continue their assigned prophylactic regimen for at least 6 months.
Drug: Valganciclovir (Valcyte)

Dosing: Standard adult dose will be 450 mg orally once daily. For pediatric patients, dosing will be weight-based 15 mg/kg/dose once daily; maximum dose: 450 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.

For pediatric patients who could not swallow pills, Valcyte also comes in the form of suspension (prepared by National Taiwan University Hospital in-house pharmacy).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to new-onset CMV viremia
Time Frame: up to 2 years
up to 2 years
Time to new-onset EBV viremia
Time Frame: up to 2 years
up to 2 years
Cumulative incidence of new-onset CMV viremia
Time Frame: 6 months, 1year, and 2 years
6 months, 1year, and 2 years
Cumulative incidence of new-onset EBV viremia
Time Frame: 6 months, 1 year, and 2 years
6 months, 1 year, and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone Marrow Suppression
Time Frame: 6 months, 1 year, 2 years
The cumulative incidence of specific cytopenia (leukopenia, neutropenia, thrombocytopenia and anemia respectively) in each treatment arm will be compared.
6 months, 1 year, 2 years
Significantly declined renal function at 2 years post-transplant
Time Frame: 2 years
The incidence of significant decline in renal function (e.g., >20% decrease from baseline or progression to CKD stage 5) will be compared between groups
2 years
Other adverse events during study period
Time Frame: 2 years
The incidence of other adverse events will be tabulated and compared between groups
2 years
Magnitude of Viral Load in New-Onset CMV Viremia
Time Frame: 2 years
For patients who develop new-onset CMV viremia, the peak CMV viral load (IU/mL) during the viremic episode will be identified.
2 years
Magnitude of Viral Load in New-Onset EBV Viremia
Time Frame: 2 years
For patients who develop new-onset EBV viremia, the peak EBV viral load (IU/mL) during the viremic episode will be identified.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202507077MINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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