Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)
Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
研究概览
详细说明
This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.
Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Bruxelles、比利时
- Service de Pneumologie
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Grenoble、法国
- Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,
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Lyon、法国
- Service de Pneumologie, HCL Lyon
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Marseille、法国
- ApHm -Chirurgie thoracique
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Nantes、法国
- Service de Pneumologie-CHU de Nantes
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Paris、法国
- Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou
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Paris、法国
- Service de Pneumologie - CH de Suresnes
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Paris、法国
- Service de Pneumologie - Phtisiologie - Hôpital Bichat
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Strasbourg、法国
- Service de Pneumologie - CHU de Strasbourg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Male and female patients aged 18 years or more
- CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time
- Patients on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)
- Patients without progressive chronic pathology jeopardizing short term patient and graft survival
- Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)
- Patients giving their free and informed written consent to participate in this study
- Patients with a health insurance policy or registered under a health insurance program
Exclusion Criteria:
- Patients aged less than 18 years or patients over 18 years under guardianship
- Patients who disagree with this research
- Patients with a contra-indication to receiving tacrolimus or MMF
- Patients on cyclosporine, sirolimus or everolimus
- Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)
- Patients infected by Burkholderia cenocepacia (Burkholderia cepacia genomovar III)
- Patients receiving HIV protease inhibitors (major pharmacokinetic interaction with tacrolimus)
- Pregnant or breastfeeding women or those of child-bearing age who do not use an efficient contraceptive method
- Drug users or patients suffering from neuro-psychiatric disorders preventing them from both proper comprehension of the protocol and reliable consent
- Patients already participating in another interventional clinical trial
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1
Optimized TDM of tacrolimus and MMF dosing
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Tacrolimus: daily oral dose divided into 2 doses (morning and evening).
MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
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有源比较器:2
Current tacrolimus and MMF dosing strategies
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Tacrolimus: daily oral dose divided into 2 doses (morning and evening).
MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Immunosuppressive treatment failure
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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次要结果测量
结果测量 |
大体时间 |
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Efficacy score
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Toxicity score
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Benefit/risk ratio
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Each event composing the composite criterion
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Overall cost of patients monitoring
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Pharmacogenetic and proteomic analysis
大体时间:Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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合作者和调查者
调查人员
- 研究主任:Pierre MARQUET, MD、Chu Limoges
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Tacrolimus and MMF的临床试验
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis Obispo完全的
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Sykehuset Asker og BaerumUllevaal University Hospital完全的
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University of British ColumbiaSocial Sciences and Humanities Research Council of Canada完全的
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Dana-Farber Cancer Institute邀请报名