Single-center, Non-interventional, Retrospective Study on the Outcomes of Infection by CMV, Treatment Patterns, and Healthcare Resource Utilization Among CMV Recipients Kidney Transplant in Brazil
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of infection, CMV disease, and tissue invasive disease.
研究概览
简要总结
This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable.
详细描述
Data will be collected from medical records and will include transplant recipient characteristics, transplant-related information, CMV status, clinical outcomes, treatment patterns, healthcare resource utilization and captured on an electronic Intake Form.
Study-specific Case Report (eCRF) The sponsor will create a Statistical Analysis Plan (SAP) before collection begins of data. The eCRF system will comply with research regulations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Received a single kidney transplant after January 1, 2018
- •Age over 18 years at time of kidney transplant.
- •It was under preemptive strategy.
- •Diagnosed with CMV infection/disease within the first 12 months after kidney transplant.
- •Follow-up information is available in medical records for at least 12 months after confirmation of CMV infection, or even loss of the allograft, death of the recipient or loss of follow-up of the receiver, when/if applicable.
排除标准
- •Diagnosed as a carrier of the human immunodeficiency virus (HIV+), hepatitis B virus and/or hepatitis C before kidney transplantation.
- •Participation in any interventional study during the period between kidney transplantation and a period of 12 months after CMV diagnosis.
结局指标
主要结局
Incidence of infection, CMV disease, and tissue invasive disease.
时间窗: 12 months
Incidence of infection, CMV disease, and tissue invasive disease.
次要结局
- Incidence recurrent CMV infection/disease(12 months)
- Incidence of refractory CMV infection/disease(12 months)
研究者
Helio Tedesco Silva Junior
Principal investigator
Hospital do Rim e Hipertensão