NCT07042035招募中不适用
Pharmacokinetic Study, Effectiveness, and Safety of the Tacrolimus Formulation Based on Melt-Dose® Technology (LCPT) as an Immunosuppressive Treatment for Lung Transplant Patients, Under Usual Clinical Practice Conditions.
Chiesi España, S.A.U.2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年10月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .
研究概览
简要总结
To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥18 years old.
- •Patients who have received a first unilateral or bilateral lung transplant.
- •Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.
- •Patients with a treatment duration expected to be ≥12 months.
- •The patient (or their representative) can sign the informed consent to participate in the study.
排除标准
- •Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.
- •Patients with an estimated survival of <12 months
- •Patients diagnosed with cystic fibrosis
- •Patients diagnosed with scleroderma.
- •Patients diagnosed with a systemic disease affecting the digestive system.
- •Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study.
- •Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.
- •Pregnant women, those planning to become pregnant, or those who are breastfeeding.
- •Patients who are unable to complete the study.
- •Patients who have not signed the informed consent.
结局指标
主要结局
To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .
时间窗: 1 year of follow up
Cmin Tacrolimus dose
次要结局
- To assess the pharmacokinetic parameters of LCPT ( concentration/dose ratio (C/D)).(1 year)
- To assess clinical effectiveness (acute rejection).(1 year)
- To assess lung function (spirometry).(1 year)
- To assess renal function (glomerular flow rate).(1 year)
- To assess the most frequent complications in lung transplant.(1 year)
- To assess adverse events.(1 year)
研究者
研究点 (2)
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