NCT00195429已完成4 期
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 47 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 主要终点
- Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
研究概览
简要总结
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
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
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease, with patients scheduled to receive a kidney transplant.
- •Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
- •Signed informed consent.
排除标准
- •Evidence of active systemic or localized major infection at the time of initial study drug administration;
- •Multiple organ transplants;
- •Any pathology or medical condition that can interfere with this protocol study proposal.
- •Other exclusion applies.
研究组 & 干预措施
Sirolimus + Tacrolimus
Experimental
干预措施: Tacrolimus (Drug)
Sirolimus + Tacrolimus
Experimental
干预措施: Sirolimus (Drug)
Sirolimus + Prednisone
Active Comparator
干预措施: Sirolimus (Drug)
Sirolimus + Prednisone
Active Comparator
干预措施: prednisone (Drug)
结局指标
主要结局
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
时间窗: 12 months
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
次要结局
- Creatinine Clearance Rate(12 months)
研究者
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