Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients

NCT07430683 | Active Not Recruiting Phase 4

• 1 other identifier: R-2024-1301-202
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation. In intermediate-risk recipients (seropositive, R+ recipient) of living donor kidney transplants, optimal prevention strategies remain debated, particularly in the setting of basiliximab-based induction therapy. This open-label clinical trial aims to compare the incidence of CMV infection or disease in intermediate-risk (R+) living donor kidney transplant recipients receiving valganciclovir prophylaxis versus a preemptive therapy strategy. All patients receive basiliximab-based immunosuppression as part of standard clinical practice. Participants were enrolled between March 1, 2024 and July 31, 2025. Patients are followed for 12 months post-transplantation to assess the primary outcome of CMV infection or disease. Secondary outcomes include graft function, acute rejection episodes, and other infectious complications. The results of this study may help define the optimal CMV prevention strategy in intermediate-risk living donor kidney transplant recipients under basiliximab-based immunosuppression.

Conditions

Cytomegalovirus Infections

Keywords

Cytomegalovirus; Kidney Transplant; Living Donor; Valganciclovir; Preemptive Therapy; Basiliximab

Outcome Measures

Primary Outcomes (1)

• Incidence of CMV infection and/or CMV disease

  CMV infection is defined as detectable CMV DNAemia by quantitative PCR. CMV disease is defined as CMV DNAemia plus compatible clinical syndrome (e.g., fever, malaise, cytopenias) and/or organ involvement (e.g., pneumonitis, colitis, pancreatitis)

  Within 12 months post-transplant

Study Arms (2)

Valganciclovir Prophylaxis

EXPERIMENTAL

Participants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes

Drug: Valganciclovir Prophylaxis

Preemptive Therapy (CMV PCR Monitoring)

ACTIVE COMPARATOR

Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes.

Diagnostic Test: Preemptive Therapy (CMV PCR Monitoring)

Interventions

Valganciclovir Prophylaxis DRUG

Participants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes

Valganciclovir Prophylaxis

Preemptive Therapy (CMV PCR Monitoring) DIAGNOSTIC_TEST

Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes.

Preemptive Therapy (CMV PCR Monitoring)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• First living-donor kidney transplant.
• Intermediate CMV risk (recipient seropositive \[R+\], donor positive or negative \[D+/D-\]).
• Induction immunosuppression with basiliximab. 5.-Ability to provide written informed consent.

You may not qualify if:

• Multi-organ transplant recipients (e.g., pancreas-kidney, liver-kidney).
• Deceased donor transplant recipients.
• Primary non-function of the graft.
• Hyperacute rejection.
• Death within the first month post-transplant.
• Early graft loss due to surgical complications.

Sponsors & Collaborators

• University of Guadalajara: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (6)

• Andrade-Sierra J, Heredia-Pimentel A, Rojas-Campos E, Ramirez Flores D, Cerrillos-Gutierrez JI, Miranda-Diaz AG, Evangelista-Carrillo LA, Martinez-Martinez P, Jalomo-Martinez B, Gonzalez-Espinoza E, Gomez-Navarro B, Medina-Perez M, Nieves-Hernandez JJ. Cytomegalovirus in renal transplant recipients from living donors with and without valganciclovir prophylaxis and with immunosuppression based on anti-thymocyte globulin or basiliximab. Int J Infect Dis. 2021 Jun;107:18-24. doi: 10.1016/j.ijid.2021.04.032. Epub 2021 Apr 14.

  PMID: 33862205 BACKGROUND

• Witzke O, Hauser IA, Bartels M, Wolf G, Wolters H, Nitschke M; VIPP Study Group. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: 1-year results of a randomized clinical trial. Transplantation. 2012 Jan 15;93(1):61-8. doi: 10.1097/TP.0b013e318238dab3.

  PMID: 22094954 BACKGROUND

• Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.

  PMID: 29166336 BACKGROUND

• Fehr T, Cippa PE, Mueller NJ. Cytomegalovirus post kidney transplantation: prophylaxis versus pre-emptive therapy? Transpl Int. 2015 Dec;28(12):1351-6. doi: 10.1111/tri.12629. Epub 2015 Jul 27.

  PMID: 26138458 BACKGROUND

• Villeneuve C, Rerolle JP, Couzi L, Westeel PF, Etienne I, Esposito L, Kamar N, Buchler M, Thierry A, Marquet P, Monchaud C. The Cost-effectiveness of Valganciclovir Prophylaxis Versus Preemptive Therapy in CMV R+ Kidney Transplant Recipients Over the First Year Posttransplantation. Transplant Direct. 2024 Jul 26;10(8):e1678. doi: 10.1097/TXD.0000000000001678. eCollection 2024 Aug.

  PMID: 39076520 BACKGROUND

• Reischig T, Vlas T, Kacer M, Pivovarcikova K, Lysak D, Nemcova J, Drenko P, Machova J, Bouda M, Sedivcova M, Kormunda S. A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 May 1;34(5):920-934. doi: 10.1681/ASN.0000000000000090. Epub 2023 Feb 2.

  PMID: 36749127 BACKGROUND

Related Links

• KDIGO Clinical Practice Guidelines for Kidney Transplantation

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jorge Andrade-Sierra, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to either valganciclovir prophylaxis or preemptive therapy. Each participant received only one intervention, and outcomes were assessed independently over 12 months

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)