Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Median Tacrolimus Sublingual Trough Level
研究概览
简要总结
Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.
详细描述
Initial doses will be given via sublingual route and a steady state trough level will be collected after 4 consecutive doses. Participants will then switched to oral tacrolimus, the dose adjusted for a goal trough 8-12ng/mL, and another steady state trough will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
- •Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)
排除标准
- •Vulnerable populations
- •Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
- •Lacking the capacity to consent in English and declining to participate in research
研究组 & 干预措施
Allogeneic blood or marrow transplantation
Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Median Tacrolimus Sublingual Trough Level
时间窗: 14 days
Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL.
次要结局
- Median Sublingual (SL) to Oral (PO) Ratio(14 days)
研究者
Heather P May
Principal Investigator
Mayo Clinic