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NCT Number: NCT07430683

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

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.

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidad de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

About this study

Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation and is associated with increased morbidity, acute rejection, and impaired graft survival. Recipients at intermediate CMV risk (seropositive recipients, R+) represent a large proportion of living-donor kidney transplant patients; however, the optimal prevention strategy in this population remains controversial.

Two main preventive approaches are currently used: universal antiviral prophylaxis and a preemptive therapy strategy based on viral load monitoring. While both strategies are accepted in clinical practice, comparative evidence in intermediate-risk living donor recipients receiving basiliximab induction therapy is limited, particularly in single-center settings in Mexico.

This single-center, open-label randomized controlled trial was conducted at the Transplant Division of UMAE Hospital de Especialidades, Centro Médico Nacional de Occidente (IMSS), Mexico. Adult recipients undergoing first living-donor kidney transplantation at intermediate CMV risk and receiving basiliximab induction were randomized to either a universal prophylaxis strategy with valganciclovir or a preemptive monitoring-based approach. All participants received standard maintenance immunosuppression and were followed for 12 months after transplantation.

The study aims to compare the effectiveness of these two prevention strategies in reducing CMV infection and disease, as well as evaluating associated hematologic adverse events and acute rejection episodes. The findings are expected to contribute evidence to guide CMV prevention strategies in intermediate-risk kidney transplant recipients in similar healthcare settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -Age ≥18 years.
  • -First living-donor kidney transplant.
  • -Intermediate CMV risk (recipient seropositive [R+], donor positive or negative [D+/D-]).

4-Induction immunosuppression with basiliximab. 5.-Ability to provide written informed consent.

Exclusion criteria

  • -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.

Treatment and study plan

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

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.

Primary outcomes

  1. Incidence of CMV infection and/or CMV disease

    Time frame: Within 12 months post-transplant

    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)

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Official study title

Incidence of Cytomegalovirus Infection or Disease Using Valganciclovir Prophylaxis Versus Preemptive Therapy in Intermediate-Risk (R+) Living Donor Kidney Transplant Recipients Receiving Basiliximab-Based Immunosuppression: An Open-Label Clinical Trial (PREVAIL-KT)

Acronym: (PREVAIL-KT)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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