Clinical trial · Interventional
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.
NCT07294547CI-TRIAL-00099352recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antiviral Prophylaxis | — | UNRESOLVED | — |
| EBV Infection | — | UNRESOLVED | — |
| Kidney Transplantation, Cytomegalovirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valacyclovir (Valtrex) | Drug | — | UNRESOLVED |
| Valganciclovir (Valcyte) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group (Valacyclovir)
- description
- 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.
- interventionNames
- Drug: Valacyclovir (Valtrex)
- type
- ACTIVE_COMPARATOR
- label
- Control group (Valganciclovir)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDKim 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. PMID 40045190
- BACKGROUNDReischig 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. PMID 25424991
- BACKGROUNDHoshino 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. PMID 19740997
- BACKGROUNDCardoso 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. PMID 39510821