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

NCT07294547 | Recruiting

• 1 other identifier: 202507077MINB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation, Cytomegalovirus Infections; EBV Infection; Antiviral Prophylaxis

Keywords

Non-Inferiority Assessment of Valacyclovir versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (4)

• Time to new-onset CMV viremia

  up to 2 years

• Time to new-onset EBV viremia

  up to 2 years

• Cumulative incidence of new-onset CMV viremia

  6 months, 1year, and 2 years

• Cumulative incidence of new-onset EBV viremia

  6 months, 1 year, and 2 years

Secondary Outcomes (5)

• Bone Marrow Suppression

  6 months, 1 year, 2 years

• Significantly declined renal function at 2 years post-transplant

  2 years

• Other adverse events during study period

  2 years

• Magnitude of Viral Load in New-Onset CMV Viremia

  2 years

• Magnitude of Viral Load in New-Onset EBV Viremia

  2 years

Study Arms (2)

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.

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.

Drug: Valganciclovir (Valcyte)

Interventions

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.

Experimental Group (Valacyclovir)

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).

Control group (Valganciclovir)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 40045190 BACKGROUND

• Reischig 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 BACKGROUND

• Hoshino 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 BACKGROUND

• Cardoso 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 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections; Epstein-Barr Virus Infections

Interventions

Valacyclovir; Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ganciclovir

Central Study Contacts

Hou-Xuan Huang, MD

CONTACT

886-2312-3456; hxhuang@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

TW (1)