Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- CMV Infection
研究概览
简要总结
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
- Is letermovir easier for patients to tolerate than valganciclovir?
- How long does it take for a CMV infection to appear in each group?
- Are there differences in "breakthrough" CMV infections between the two medications?
- For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
详细描述
The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients.
A 3:1 match of historical valganciclvoir:letermovir arm
• Matching criteria:
- Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab)
- Delayed graft function (dialysis within one week of kidney transplant)
- MMF dose at de novo discharge (weight-based vs non-weight based)
Study Arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •(both arms):
- •≥18 years old
- •Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
- •Inclusion Criteria (letermovir arm):
- •Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
- •Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
排除标准
- •(both arms):
- •Multiorgan organ transplant
- •Received previous solid organ transplant or HSCT
- •Unable to take oral medications
- •Uncontrolled infections at the time of enrollment
- •Hemodynamically unstable or on mechanical ventilation at the time of enrollment
- •Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor
- •Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation
- •Received any anti-CMV drug treatment within 7 days prior to enrollment
- •Current user of recreational or illicit drugs or alcohol dependence
- •History of CMV disease prior to enrollment
- •Exclusion Criteria (letermovir arm):
- •Previously participated in a letermovir study or any other study with CMV investigational agents
- •On dialysis or plasmapheresis at the time of enrollment
- •Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations
- •Child-Pugh Class C severe hepatic insufficiency
- •Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study
- •Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine
研究组 & 干预措施
Letermovir
Prospective letermovir prophylaxis
干预措施: Letermovir (Drug)
Valganciclovir
Historical valganciclovir prophylaxis
干预措施: Valganciclovir CMV Prophylaxis (Drug)
结局指标
主要结局
CMV Infection
时间窗: 12 months post kidney transplant
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.
次要结局
未报告次要终点
研究者
Elisabeth Kincaide
Principle Investigator, Solid Organ Transplant Clinical Pharmacy Specialist, Adjoint Assistant Professor
Bexar County Hospital District dba University Health