NCT00133172终止4 期
Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 85
- 主要终点
- Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
- •Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
- •Subject is 18 years of age or over at the time of transplant.
- •If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
排除标准
- •Recipients of a kidney from a donor 60 years of age or older
- •Recipients of donation after cardiac death (DCD) donors
- •Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
- •Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
- •Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
- •Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
- •Subjects receiving an allograft with cold ischemia time 24 hours or greater
- •Subjects who have received an investigational drug within three months prior to randomization
- •Subjects who are breastfeeding
- •Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
- •Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol
研究组 & 干预措施
1
Experimental
Steroid rapid 5-day withdrawal
干预措施: Tacrolimus (Drug)
1
Experimental
Steroid rapid 5-day withdrawal
干预措施: mycophenolate mofetil (Drug)
1
Experimental
Steroid rapid 5-day withdrawal
干预措施: Prednisone (Drug)
2
Active Comparator
Standard steroid maintenance
干预措施: Tacrolimus (Drug)
2
Active Comparator
Standard steroid maintenance
干预措施: mycophenolate mofetil (Drug)
2
Active Comparator
Standard steroid maintenance
干预措施: Prednisone (Drug)
结局指标
主要结局
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
时间窗: 3 months post transplant
次要结局
- Biopsy proven chronic allograft nephropathy(CAN)(2 years post transplant)
- Patient and graft survival rates(End of study (5 years))
研究者
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