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临床试验/NCT00305396
NCT00305396已完成4 期

Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年4月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
2
主要终点
Patient and graft survival

研究概览

简要总结

A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

详细描述

Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary cadaver or non-HLA identical living donor kidney transplant. -

排除标准

  • HIV HCV Pregnancy Age < 18 years Malignancy

结局指标

主要结局

Patient and graft survival

Biopsy proven acute rejection

Serum creatinine

次要结局

  • post-transplant diabetes
  • Hyperlipidemia
  • wound infections
  • lymphoceles

研究者

申办方类型
Other

研究点 (2)

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