Evaluating Nulojix Long-Term Safety in Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 914
- 试验地点
- 36
- 主要终点
- Incidence rate of confirmed PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
研究概览
简要总结
To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.
详细描述
Time Perspective: Prospective for the majority of patients who are enrolled at the time they begin Nulojix (belatacept) treatment. Retrospective for any patients receiving Nulojix (belatacept) prior to enrollment into ENLiST Registry
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
- •Adult kidney transplant recipient (age ≥18 years at time of transplant)
- •Kidney-only transplant recipient
- •Positive EBV serostatus
- •a) EBV serostatus negative or unknown included per the investigator discretion
- •Received first dose of Nulojix (Belatacept) within ≤ 14 days of renal transplant
- •Received first dose of Nulojix (Belatacept) as part of normal clinical care (i.e. not as part of a clinical trial)
排除标准
- •Received Nulojix (belatacept) for non kidney transplants
- •<18 years of age at time of transplant
- •Received first dose of Nulojix (belatacept) as an assigned study drug under a clinical trial protocol
- •EBV-serostatus negative or unknown patients, except by investigator decision
- •Patient who did not receive Belatacept for de novo treatment
- •Recipient of concurrent or extant non-kidney organ transplant
- •Received first dose of Nulojix (belatacept) > 14 days after date of renal transplant
研究组 & 干预措施
Adult de novo EBV-seropositive kidney-transplant recipients
Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)
干预措施: No Intervention (Drug)
结局指标
主要结局
Incidence rate of confirmed PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
时间窗: Every 6 months for up to 72 months
Incidence rate of confirmed CNS PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
时间窗: Every 6 months for up to 72 months
Incidence rate of PML in confirmed PML in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
时间窗: Every 6 months for up to 72 months
次要结局
- Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)(Every 6 months for up to 72 months)
- Rates of graft survival observed in the Nulojix (belatacept) treated patients(Every 6 months for up to 72 months)
- Rates of patient survival observed in the Nulojix (belatacept) treated patients(Every 6 months for up to 72 months)
- Incidence rate of confirmed PTLD and confirmed CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated population(Every 6 months for up to 72 months)
- Incidence rates of total reported PTLD, reported CNS PTLD and reported PML in adult de novo EBV seropositive kidney transplant recipients treated with Nulojix (belatacept)(Every 6 months for up to 72 months)
- Incidence rates of total reported PTLD and of total reported CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated patients(Every 6 months for up to 72 months)