Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
研究概览
简要总结
The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection) vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent HSV infection).
详细描述
Maribavir has been evaluated for the prevention of CMV infection in Phase II and Phase III trials within allogeneic stem cell transplant recipients. At 6-months post-transplant, the rates of CMV infection using PCR were not different between treatment and placebo arms, although the rates of pp65 antigenemia were lower in the Maribavir group. However, these studies used a low dose of 100mg PO BID. In subsequent studies within solid organ transplantation, Maribavir dosed at 400 to 1200mg PO BID was equally efficacious to valganciclovir for the treatment of CMV infection. Of note and importance to this proposal, the rates of neutropenia were 4-5% in the Maribavir treated patients vs. 15-18% in Valganciclovir patients. Thus, at an appropriate dose, Maribavir appears to have similar efficacy to Valganciclovir in treating CMV infection with a significantly reduced incidence of neutropenia. Currently, there is a lack of randomized controlled trials assessing the safety and efficacy of adequately dosed (=400mg PO BID) Maribavir for the prevention of CMV infection in solid organ transplant recipients.
Aim 1. Assess the incidence of leukopenia in those randomized to Maribavir vs. Valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
Hypothesis 1. The incidence of clinically meaningful leukopenia, defined as a WBC count of < 3,000 cells/mm3 and a reduction in total mycophenolate dose below 1,500 mg/day or valganciclovir dose below 900mg per day (adjusted for renal function), will be significantly lower in the Maribavir arm, as compared to the Valganciclovir arm.
Aim 2. Assess the efficacy of Maribavir vs. Valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
Hypothesis 2. The incidence of CMV infection and disease will be similar between the Maribavir arm, as compared to the Valganciclovir arm, at 3-, 6-, and 12-months post-transplant.
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
- •Kidney transplant recipient at study institution
- •=7 days of transplant
- •Received at least one dose of rATG induction or patient is D+/R- CMV serostatus
排除标准
- •Age <18 years at time of transplant
- •Recipient of pancreas, liver, heart, lung transplant
- •Recipient of investigational, non-FDA approved medication
研究组 & 干预措施
Control
valganciclovir 900mg once daily
干预措施: Valganciclovir (Drug)
Intervention
maribavir 400mg twice daily
干预措施: Maribavir (Drug)
结局指标
主要结局
Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
时间窗: One year following transplant
Leukopenia is defined as a white blood cell count \<3000 cells/mm3
Compare the proportion of patients that develop cytomegalovirus (CMV) infection in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
时间窗: One year following transplant
CMV infection is defined as having at least one CMV DNA PCR test of \>1000 copies/mL
次要结局
未报告次要终点
研究者
David J. Taber
Professor-Faculty
Medical University of South Carolina