EUCTR2022-000617-13-ES进行中（未招募）1 期
A prospective, randomized, controlled trial assessing the effect of conversion from Tacrolimus-antimetabolite to Tacrolimus-mTor-inhibitors based immunosuppression to booster SARS-CoV-2-specific seroconversion after a fourth dose of SARS-CoV-2 mRNA vaccine in unresponsive Solid Organ Transplant recipients - TOR-VAX
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 50 人开始时间: 2022年3月4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
- 50
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
- •1.Patient’s age = 18 years
- •2.Time of transplantation = 1 year
- •3.Negative or very weak (<143BAU/ml) serological immune response after 3 doses of an mRNA SARS-CoV-2 vaccine
- •4.Stable renal function with an estimated GFR = 40 mL/min/1.73 m2
- •5.Urine protein to creatinine ratio < 0.8 g/g
- •6.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Previous diagnosis of T-cell mediated or antibody-mediated rejection
- •2.Previous seroconversion after any SARS-CoV-2 vaccine.
- •3.Previous COVID-19 infection
- •4.Presence of HLA donor-specific antibodies
- •5.Active cancer excluding non-melanoma skin cancer
- •6.Pregnancy
研究者
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