Kidney Transplantation, Cytomegalovirus InfectionsNCT07294547
Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study
A study testing Valacyclovir (Valtrex) and Valganciclovir (Valcyte) in people with Kidney Transplantation, Cytomegalovirus Infections and EBV Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Kidney Transplantation, Cytomegalovirus Infections, EBV Infection, Antiviral Prophylaxis
- What is being tested?
- Valacyclovir (Valtrex) and Valganciclovir (Valcyte)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hou-Xuan Huang, MD, 886-2312-3456 ext. 270282, hxhuang@ntuh.gov.tw
Yi-Jen Huang, PharmD
About this study
Official title: 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.
Read the 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.
- Being tested
- Valacyclovir (Valtrex), Valganciclovir (Valcyte)
- Keywords
- Non-Inferiority Assessment of Valacyclovir versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients
- Medical subject headings
- Cytomegalovirus Infections, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir (Valtrex)Drug
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.
Valganciclovir (Valcyte)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Valacyclovir) | Experimental | 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. Receives: Drug: Valacyclovir (Valtrex) |
| Control group (Valganciclovir) | Active comparator | 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. Receives: Drug: Valganciclovir (Valcyte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to new-onset CMV viremia
Measured: up to 2 years
Time to new-onset EBV viremia
Measured: up to 2 years
Cumulative incidence of new-onset CMV viremia
Measured: 6 months, 1year, and 2 years
Cumulative incidence of new-onset EBV viremia
Measured: 6 months, 1 year, and 2 years
Secondary outcomes (5)
Bone Marrow Suppression
The cumulative incidence of specific cytopenia (leukopenia, neutropenia, thrombocytopenia and anemia respectively) in each treatment arm will be compared.
Measured: 6 months, 1 year, 2 years
Significantly declined renal function at 2 years post-transplant
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
Measured: 2 years
Other adverse events during study period
The incidence of other adverse events will be tabulated and compared between groups
Measured: 2 years
Magnitude of Viral Load in New-Onset CMV Viremia
For patients who develop new-onset CMV viremia, the peak CMV viral load (IU/mL) during the viremic episode will be identified.
Measured: 2 years
Magnitude of Viral Load in New-Onset EBV Viremia
For patients who develop new-onset EBV viremia, the peak EBV viral load (IU/mL) during the viremic episode will be identified.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start27 Nov 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplantation, Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294547
- Sponsor's protocol ID
- 202507077MINB
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim JS, Lee NR, Park KI, Hwang HS, Lee SH, Chung BH, Jung CW, Cho JH, Park WY, Kim HJ, Jeong JC, Yang J, Lee YH, Park JB, Jeon JS, Lee J, Kim YH, Choi SJN, Oh J, Yoon HE, Kim DG, Shin HS, Ban TH, Kim MS, Ko MJ, Jeong KH; KOTRY study group. Valacyclovir for the prevention of cytomegalovirus infection after kidney transplantation. BMC Infect Dis. 2025 Mar 5;25(1):314. doi: 10.1186/s12879-025-10671-6.
PubMed 40045190Reischig T, Kacer M, Jindra P, Hes O, Lysak D, Bouda M. Randomized trial of valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):294-304. doi: 10.2215/CJN.07020714. Epub 2014 Nov 25.
PubMed 25424991Hoshino Y, Katano H, Zou P, Hohman P, Marques A, Tyring SK, Follmann D, Cohen JI. Long-term administration of valacyclovir reduces the number of Epstein-Barr virus (EBV)-infected B cells but not the number of EBV DNA copies per B cell in healthy volunteers. J Virol. 2009 Nov;83(22):11857-61. doi: 10.1128/JVI.01005-09. Epub 2009 Sep 9.
PubMed 19740997Cardoso LJC, Martins KAM, Marques PV, Teixeira IPS, Magalhaes E, Minkauskas JL, Faria IC, Ribeiro FM. Valacyclovir versus valganciclovir for cytomegalovirus prophylaxis in kidney transplant recipients: a systematic review and comparative meta-analysis. Clin Transplant Res. 2025 Mar 31;39(1):24-35. doi: 10.4285/ctr.24.0034. Epub 2024 Nov 8.
PubMed 39510821
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07294547
- Acronym / sponsor ID
- 202507077MINB
- Keywords
- Non-Inferiority Assessment of Valacyclovir versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Valacyclovir) | Experimental | Drug: Valacyclovir (Valtrex)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. |
| Control group (Valganciclovir) | Active comparator | Drug: Valganciclovir (Valcyte)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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental Group (Valacyclovir) |
| 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). | Drug | Control group (Valganciclovir) |
Primary outcome
Time to new-onset CMV viremia
Time frame: up to 2 years
Time to new-onset EBV viremia
Time frame: up to 2 years
Cumulative incidence of new-onset CMV viremia
Time frame: 6 months, 1year, and 2 years
Cumulative incidence of new-onset EBV viremia
Time frame: 6 months, 1 year, and 2 years
5 secondary outcomes
Bone Marrow Suppression
Time frame: 6 months, 1 year, 2 years
Significantly declined renal function at 2 years post-transplant
Time frame: 2 years
Other adverse events during study period
Time frame: 2 years
Magnitude of Viral Load in New-Onset CMV Viremia
Time frame: 2 years
Magnitude of Viral Load in New-Onset EBV Viremia
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 40045190Kim JS, Lee NR, Park KI, Hwang HS, Lee SH, Chung BH, Jung CW, Cho JH, Park WY, Kim HJ, Jeong JC, Yang J, Lee YH, Park JB, Jeon JS, Lee J, Kim YH, Choi SJN, Oh J, Yoon HE, Kim DG, Shin HS, Ban TH, Kim MS, Ko MJ, Jeong KH; KOTRY study group. Valacyclovir for the prevention of cytomegalovirus infection after kidney transplantation. BMC Infect Dis. 2025 Mar 5;25(1):314. doi: 10.1186/s12879-025-10671-6.
- Background: PubMed 25424991Reischig T, Kacer M, Jindra P, Hes O, Lysak D, Bouda M. Randomized trial of valganciclovir versus valacyclovir prophylaxis for prevention of cytomegalovirus in renal transplantation. Clin J Am Soc Nephrol. 2015 Feb 6;10(2):294-304. doi: 10.2215/CJN.07020714. Epub 2014 Nov 25.
- Background: PubMed 19740997Hoshino Y, Katano H, Zou P, Hohman P, Marques A, Tyring SK, Follmann D, Cohen JI. Long-term administration of valacyclovir reduces the number of Epstein-Barr virus (EBV)-infected B cells but not the number of EBV DNA copies per B cell in healthy volunteers. J Virol. 2009 Nov;83(22):11857-61. doi: 10.1128/JVI.01005-09. Epub 2009 Sep 9.
- Background: PubMed 39510821Cardoso LJC, Martins KAM, Marques PV, Teixeira IPS, Magalhaes E, Minkauskas JL, Faria IC, Ribeiro FM. Valacyclovir versus valganciclovir for cytomegalovirus prophylaxis in kidney transplant recipients: a systematic review and comparative meta-analysis. Clin Transplant Res. 2025 Mar 31;39(1):24-35. doi: 10.4285/ctr.24.0034. Epub 2024 Nov 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir (Valtrex) and Valganciclovir (Valcyte) in people with Kidney Transplantation, Cytomegalovirus Infections and EBV Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hou-Xuan Huang, MD (886-2312-3456 ext. 270282, hxhuang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to new-onset CMV viremia (time frame: up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07294547, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.