Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
研究概览
地位
详细说明
Study Design
This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.
Treatments
In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.
In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).
In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Patients aged more than 60 years and recipients of compatible renal transplant
Exclusion Criteria:
- Receptors of multiple organs;
- non-heart beating donors;
- donors aged under 5 or over 65 years;
- Patients with body mass index greater than 35
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Tacrolimus + Mycophenolate
The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
其他名称：
其他名称：
Prednisone 30mg/day
其他名称：
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
其他名称：
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
其他名称：
|
|
实验性的：Tacrolimus + Sirolimus
The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
其他名称：
Prednisone 30mg/day
其他名称：
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
其他名称：
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
其他名称：
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in estimated glomerular filtration rate from baseline
大体时间：Baseline, 1 month, 3 months, 6 months and 12 months
|
The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation.
The investigators will be measure the change in eGFR during 12 month follow-up.
Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).
|
Baseline, 1 month, 3 months, 6 months and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of cytomegalovirus Infection (CMV)
大体时间：Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.
|
The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection.
CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients.
CMV disease will be defined based on the evidence of CMV infection with related symptoms.
For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days.
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Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 16966913.6.0000.5411
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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