EUCTR2019-002795-13-ES进行中（未招募）1 期
Identification of omic biomarkers and their inter and intra-individual variability that allow improvement in the individualization of tacrolimus: uncontrolled clinical trial in pediatric patients with renal transplantation.
Fundación de Investigación Hospital Universitario La Paz0 个研究点目标入组 180 人开始时间: 2020年2月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects up to 18 years of age, both sexes included.
- •- Kidney transplants.
- •- Stable treatment with tacrolimus, as primary immunosuppressant, at the time of inclusion in the study. Stable treatment is considered when the variations in the last 3 determinations of tacrolimus levels are less than 30%, being these determinations a minimum of one week appart.
- •- Individuals who, previously informed, grant their consent to participate in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Incapacity to understand the instructions or collaborate during the development of the study.
- •- Estimated glomerular filtration <30 mL / min / 1.73m2.
- •- Graft rejection or dysfunction in the previous 6 months.
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