Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of Patients Remaining on Envarsus XR at 1 Year
研究概览
简要总结
Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.
详细描述
Lung transplantation will be performed per standard-of-care techniques. All post-transplant management, including initial triple immunosuppression, will be carried out per standard of care. Once the patient is able to take medications via the oral route, they will be converted to Envarsus XR, which will be maintained for the first year post-lung transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective arm:
- •Age ≥ 18 years
- •Received a lung transplant at NYU Langone Health
- •Be able to convert to Envarsus XR within the first month post-transplant
- •Able and willing to provide informed consent
- •Historical control:
- •Age ≥ 18 years
- •Received a lung transplant at NYU Langone Health
- •Completed one year from transplant on IR tacrolimus
排除标准
- •Prospective arm:
- •Contraindication to tacrolimus due to allergic or adverse reactions
- •Pregnant or nursing women
- •Multi-organ transplant recipient
- •Historical control:
- •Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)
研究组 & 干预措施
Envarsus XR
Envarsus XR to be initiated once patient is tolerating oral medications
干预措施: Extended-Release Tacrolimus (Drug)
IR tacrolimus (historical control)
Historical cohort of patients maintained on IR tacrolimus following transplant
干预措施: Immediate-Release Tacrolimus (Drug)
结局指标
主要结局
Percentage of Patients Remaining on Envarsus XR at 1 Year
时间窗: 1 Year Post-Transplant
The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
次要结局
- Freedom From Acute Cellular Rejection (ACR) at 1 Year(Up to 1 Year Post-Transplant)
- Composite Rejection Standardized Score (CRSS)(1 Year Post-Transplant)
- Number of Treated Episodes of ACR(Up to 1 Year Post-Transplant)
- Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)(Up to 1 Year Post-Transplant)
- Number of Participants With De Novo Donor-Specific Antibody (DSA)(Up to 1 Year Post-Transplant)
- Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline, 1 Year Post-Transplant)
- Overall Survival at 1 Year(1 Year Post-Transplant)