Randomized Conversion of Calcineurin-Inhibitors(Tacrolimus to Sirolimus),6-24 Months Post Transplant Prednisone-Free Immunosuppression Regimen: Impact of Incidence of Acute Cellular Rejection,Renal Allograft Function & Lymphocytes Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Incidence of Acute Cellular Rejection
研究概览
简要总结
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
详细描述
For this research study, between 6 and 24 Months post-transplant, we plan to prospectively randomize 2:1 renal transplant patients to either:
- Substitute tacrolimus (TAC) with sirolimus and continue mycophenolate mofetil (MMF) or
- Continue with tacrolimus (TAC) and mycophenolate mofetil (MMF)
A total of 400 patients are expected to be screened for the randomization. We expect to randomize 275 renal transplant patients into this protocol (275 donors to be recruited).
The following data will be collected at the time of randomization:
Recipient demographics: (i) age at transplantation, (ii) sex, and (iii) race.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should be adults ≥ 18- ≤ 70 years of age
- •Subjects can be either gender or of any ethnic background
- •Subjects should be single organ recipients (kidney only)
- •Subjects must be able to understand the protocol and provide informed consent.
排除标准
- •Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
- •Inability to comply with study procedures
- •Inability to sign the informed consent
- •Subjects with a significant or active infection
- •Subjects who are pregnant or nursing females
- •Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of > 400 mg/dl
- •Subjects with a platelet count <100,000mm3 white blood cell (WBC)< 2,000mm3
- •Subjects with severe proteinuria at the time of randomization (>2gm/day)
- •Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study
- •An estimated GFR<40 cc/min
- •A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer)
- •Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial
- •A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization
研究组 & 干预措施
Control
Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
干预措施: Demographic Data, Medical History, and Donor Data (Other)
Control
Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
干预措施: Blood Draws for Control Group (Procedure)
Control
Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus.
干预措施: Kidney Biopsy (Procedure)
Transition to Sirolimus Group
Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
干预措施: Sirolimus (Drug)
Transition to Sirolimus Group
Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
干预措施: Demographic Data, Medical History, and Donor Data (Other)
Transition to Sirolimus Group
Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
干预措施: Blood Draws for Experimental Group (Procedure)
Transition to Sirolimus Group
Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus
干预措施: Kidney Biopsy (Procedure)
Donors
Data and blood samples from the donors are collected in this study to contribute to the general knowledge to be used in assessing the two donor recipient groups, which are the target of this study.
干预措施: Donor Blood Draws (Procedure)
Donors
Data and blood samples from the donors are collected in this study to contribute to the general knowledge to be used in assessing the two donor recipient groups, which are the target of this study.
干预措施: Donor Information (Other)
结局指标
主要结局
Incidence of Acute Cellular Rejection
时间窗: Assessed at 6 Months, 12 Months, 24 Months, months 24 reported
The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil/Cellcept ® and either tacrolimus/Prograf ® (Group #1) or mycophenolate mofetil/Cellcept ® and sirolimus/Rapamune® (Group #2) impacts the incidence of acute cellular rejection in post-kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
次要结局
- Evaluate if CI Conversion Impacts on Lipid Profile, Incidence of Hypertension, Malignancies, and Opportunistic Infections and Post-transplant DM(Assessed at 6 Months, 12 Months, 24 Months, months 24 reported)
- Patient and Graft Survival(Assessed at 6 Months, 12 Months, 24 Months, months 24 reported)
- Renal Allograft Function Calculated With e-GFR and Proteinuria(Assessed at 6 Months, 12 Months, 24 Months, months 24 reported)
- Percentage of Regulatory T Cells(Assessed at 6 Months, 12 Months, 24 Months, months 24 reported)
研究者
Lorenzo Gallon
Associate Professor
Northwestern University