Cytomegalovirus Infections
Conditions
Keywords
Cytomegalovirus, Kidney Transplant, Living Donor, Valganciclovir, Preemptive Therapy, Basiliximab
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.
Detailed description
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.
Interventions
DRUGValganciclovir Prophylaxis
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
DIAGNOSTIC_TESTPreemptive Therapy (CMV PCR Monitoring)
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.
Sponsors
University of Guadalajara
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. -Age ≥18 years. 2. -First living-donor kidney transplant. 3. -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
1. -Multi-organ transplant recipients (e.g., pancreas-kidney, liver-kidney). 2. -Deceased donor transplant recipients. 3. -Primary non-function of the graft. 4. -Hyperacute rejection. 5. -Death within the first month post-transplant. 6. -Early graft loss due to surgical complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CMV infection and/or CMV disease | 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) |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORJorge Andrade-Sierra, PhD
University of Guadalajara
Outcome results
None listed