Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 25
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).
In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults more than and equal to (≥) 18 years of age at index date.
- •Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.
- •If ESRD (including participants on peritoneal dialysis or hemodialysis): participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (<) 15 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).
- •If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to <30 mL/min/1.73m^2 at index.
- •Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date.
- •Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period.
- •Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir.
- •Informed consent provided (where required by local regulations) before data collection commences.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years)
An AE is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event.
次要结局
- Number of Participants With Adverse Events of Special Interest (AESIs)(Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years))