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)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of CMV infection and/or CMV disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Valganciclovir 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
干预措施: Valganciclovir Prophylaxis (Drug)
Preemptive 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.
干预措施: Preemptive Therapy (CMV PCR Monitoring) (Diagnostic Test)
结局指标
主要结局
Incidence of CMV infection and/or CMV disease
时间窗: 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)
次要结局
未报告次要终点