Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus. Phase 4 Clinical Trial. TIMTOR STUDY.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- CMV disease incidence
研究概览
简要总结
The overall objective of this project is to optimise preventive treatment of CMV infection/disease in renal transplant recipients at increased risk of CMV post-transplantation. The specific objectives are: (1) To compare the incidence of CMV infection/disease at 6 months post-transplant in Ig G CMV positive (R+CMV) recipients receiving induction treatment with thymoglobulin and one of the two maintenance immunosuppressive treatment regimens used in routine clinical practice : tacrolimus and MTOR inhibitors (group 1) or tacrolimus and mycophenolic acid (group 2); (2) To monitor CMV-specific cellular immunity before transplantation, at 15, 30 and 90 days post-transplantation. For this purpose, an exploratory phase 4 clinical trial has been designed in which will select 30 R+CMV patients receiving renal transplantation with induction treatment with thymoglobulin. After signing informed consent, patients will be randomised to receive one of the two immunosuppression regimens indicated above. The patients in group 1 will receive early therapy as a CMV prevention strategy and patients in group 2 will receive universal prophylaxis for 3 months. Follow-up visits to will be conducted according to the usual protocol and clinical and virological variables will be collected. In addition, blood samples will be collected for the assessment of CMV-specific cellular immunity before and after transplantation. The primary endpoint is the presence of CMV infection/disease post-renal transplantation at 6 months. Secondary variables include renal function, acute rejection, patient and graft survival and the occurrence of surgical or haematological complications.
详细描述
HYPOTHESIS The use of immunosuppressive maintenance therapy including mTOR inhibitors versus the use of mycophenolic acid in kidney transplant patients with an increased risk of post-transplant CMV disease (R+CMV receiving induction with thymoglobulin) will allow optimisation of the preventive treatment of these patients, presenting a similar incidence of post-transplant CMV disease in both groups and better maintenance of CMV-specific cellular immunity post-transplant.
OBJECTIVES General Objective: To improve the preventive treatment of CMV disease in renal transplant patients at increased risk.
Main Objectives: (1) To compare the incidence of CMV disease at 6 months post-renal transplant in Ig G CMV-positive recipients receiving induction treatment with thymoglobulin and maintenance treatment with tacrolimus and mTOR inhibitors (group 1) with CMV prevention strategy of anticipatory therapy or tacrolimus and mycophenolic acid (group 2) with CMV prevention strategy with universal prophylaxis. (2) 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.
Secondary Objectives: (3) To compare between the two groups the incidence of CMV infection, delayed initial graft function, acute rejection diagnosed by renal biopsy, renal function and patient and graft survival in the first 6 months post-transplant. (4) To compare between the two groups the presence of surgical (lymphocele requiring intervention) or haematological (neutropenia) complications in the first 6 months post-transplantation.
STUDY DESIGN Phase IV, exploratory, randomised, open-label, single-centre, exploratory clinical trial to evaluate the effectiveness of CMV prevention strategies comparing early therapy vs. universal prophylaxis in Ig G CMV-positive kidney transplant recipients treated with thymoglobulin receiving tacrolimus and mTOR inhibitors (group 1) vs. tacrolimus and mycophenolic acid (group 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or more.
- •Positive pre-transplant 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 pre-transplant Ig G CMV serology.
- •HIV-infected patients.
- •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 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
CMV disease incidence
时间窗: 6 months after renal transplant
To compare the incidence of CMV disease at 6 months post-renal transplantation in Ig G CMV-positive recipients receiving induction treatment with thymoglobulin and maintenance treatment with tacrolimus and mTOR inhibitors (group 1) with CMV prevention strategy of early therapy or tacrolimus and mycophenolic acid (group 2) with CMV prevention strategy with universal prophylaxis.
Monitor CMV-specific cellular immune response prior to transplantation
时间窗: 4 months
Monitor CMV-specific cell-mediated immune response before transplantation and at 15, 30 and 90 days post-transplantation in each of the two treatment groups using Quantiferon-CMV.
次要结局
- To compare between the two groups the incidence of CMV infection, delayed initial graft function, acute rejection diagnosed by renal biopsy, renal function and patient and graft survival(6 months)
- To compare the presence of surgical (lymphocele requiring intervention) or haematological (neutropenia) complications(6 months)
研究者
María Ovidia López Oliva
Dra.
Hospital Universitario La Paz