2025-520742-29-00招募中3 期
Efficacy and Safety Clinical Trial for Immune-Guided Prevention of CMV Infection in Low-Risk Kidney Transplantation. (INMUNOVIR Study)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 9
- 主要终点
- Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation.
研究概览
简要总结
Compare the efficacy and safety of immune-guided prophylaxis versus preemptive therapy in kidney transplant recipients.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •CMV-seropositive kidney transplant recipients
- •Must have a negative pregnancy test (non-menopausal women)
排除标准
- •HIV-infected patients
- •Patients with multivisceral transplants
- •Those who are not expected to receive universal prophylaxis
- •Receiving induction therapy with anti-thymocyte globulin (ATG)
- •Having HLA excluded from QF-CMV
- •Unable to comply with the follow-up protocol
- •Having CMV replication/disease prior to inclusion
结局指标
主要结局
Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation.
Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation.
Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.
Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.
次要结局
- Safety: number of days with valganciclovir (at 6 and 12 months post-transplant) and proportion of patients with adverse events occurring at a frequency >10% (at 6 months post-transplant).
- Efficacy/safety: CMV disease/neutropenia combination assessed at 6 and 12 months using DOOR ("Desirability of Outcome Ranking"). The best outcome is no CMV disease/replication without neutropenia (<1500 mm³), while the worst is CMV disease/replication with neutropenia. DOOR ranks patient outcomes and estimates the probability of a better result in one group. A >50% probability, with 95% confidence intervals excluding 50%, indicates a significantly better outcome.
研究者
Dr. Julian Carlos de la Torre Cisneros
Scientific
Fundacion Para La Investigacion Biomedica De Cordoba
研究点 (9)
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