2024-516596-32-00招募中4 期
TRANSPGx: A multicentre, controlled, randomised and single-blind, adaptive phase IV protocol to evaluate effectiveness and cost-effectiveness of pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease population cohort
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz6 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年1月17日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml.
研究概览
简要总结
To assess the effectiveness of a pre-emptive pharmacogenetic strategy in reaching tacrolimus target plasma concentrations.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase IV, single blind, multicenter, randomized, low-intervention, adaptive clinical trial to assess
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- •Subject or their legally authorized representative has voluntarily signed the informed consent document.
- •Participant is on the waiting list for a kidney transplant.
- •Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
- •Subjects must be naïve to any genotyping test of the following genes: CYP3A5.
排除标准
- •Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
- •History of renal, heart, and/or liver transplant.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
- •Any condition or situation precluding or interfering the compliance with the protocol.
- •Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
结局指标
主要结局
Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml.
Tacrolimus concentrations levels at day 4 (+/-1d) will be the effectiveness surrogate outcome. It will be considered therapeutic range levels between 7-10 ng/ml.
次要结局
- Ratio that divides the differences in costs between both treatments by the difference in effectiveness between both treatments.
- Number and percentage of patients achieving tacrolimus target plasma concentrations.
- Number and percentage of patients with transplant rejection. Transplant rejection will be considered if there is histological confirmation and/or the patient initiates any type of therapy aimed at treating rejection (e.g. corticosteroids).
- Rate of adverse events associated to treatment.
- Healthcare expenditure related to predefined events of interest: Any costs made as a result of an adverse event.
- Incidence of discontinuation or treatment modification due to lack of effective related to the drug of inclusion.
- Identification of new actionable genes/relevant polymorphisms within the predefined population subsets.
- Novel prognostic and predictive genetic biomarkers of tacrolimus safety and effectiveness will be assessed trough techniques only available at Nation Centre of Oncological Investigations (CNIO) and genome-wide association studies when applicable.
研究者
Borobia Perez, Alberto Manuel
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (6)
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