Use of tacrolimus and MTOR inhibitors with anticipatory therapy vs. tacrolimus and mycophenolic acid with universal prophylaxis in renal recipients at high risk of post-transplant cytomegalovirus. Phase IV clinical trial (TIMTOR STUDY).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.
研究概览
简要总结
The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia. Monitor CMV-specific cellular immune response before transplantation and at 15, 30 and 90 days post-transplantation in each of the two treatment groups using Quantiferon-CMV.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 4, exploratory, randomized, open-label, single-center, exploratory clinical trial to evaluate
- 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
- •Age more than or equal 18 years.
- •Positive pretransplant Ig G CMV serology
- •Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).
- •Agree to participate in the study by signing the informed consent form.
排除标准
- •Patients with negative pretransplant Ig G CMV serology
- •Patients infected with HIV.
- •Patients receiving induction therapy with basiliximab
- •Patients who cannot comply with the follow-up protocol.
- •Patients who cannot receive iMTOR as initial maintenance immunosuppressive therapy, such as patients with chronic kidney disease secondary to hepatorenal polycystic kidney disease and those patients who are expected to undergo complex vascular surgery.
- •Patients who for any reason should not be included in the study according to the evaluation of the research team.
结局指标
主要结局
Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.
Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.
次要结局
- Recipient demographic variables: gender and age
- Recipient variables related to chronic kidney disease (CKD): etiology of CKD, renal replacement therapy (RRT) prior to transplantation, time on RRT in months.
- Donor variables: demographics (age and sex), cause of death, donor type (living, cadaveric and cadaveric donor type), Ig G CMV serology.
- Peri-transplant variables
- CMV-related variables
研究者
María Ovidia López Oliva
Scientific
Hospital Universitario La Paz