CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anti-CMV IgG antibody level: Day 0
研究概览
简要总结
The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-70 year old) kidney transplant recipients
- •Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion
- •CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor
- •EBV IgG Positive
排除标准
- •Pregnant people
- •Subjects unwilling to sign consent and complete follow up visits
- •Subjects with IgA immunodeficiency
- •Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment
- •Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent
研究组 & 干预措施
Single Dose, Day 0
CMVIG 150 mg/kg x 1 at Day 0. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
干预措施: Cytogam (Drug)
Two Doses, One Week
CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 7. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
干预措施: Cytogam (Drug)
Two Doses, Four Weeks
CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 28. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
干预措施: Cytogam (Drug)
结局指标
主要结局
Anti-CMV IgG antibody level: Day 0
时间窗: Day 0, pre-infusion
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 7
时间窗: Day 7
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 14
时间窗: Day 14
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 21
时间窗: Day 21
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 28
时间窗: Day 28
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 56
时间窗: Day 56 after last dose of CMVIG
Measured with ELISA testing
次要结局
未报告次要终点