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临床试验/NCT02459977
NCT02459977Unknown不适用

The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Incidence of rejection

研究概览

简要总结

Basiliximab has been a routine induction therapeutic agent even for well-matched living kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is a different drug from cyclosporine, the investigators study the usefulness of tacrolimus-based immunosuppression without basiliximab in well matched living KT.

详细描述

The investigators omit basiliximab induction therapy in patients who underwent one to three-HLA mismatched living donor renal transplantation. Participants should receive ABO compatible and T-flow negative transplants. The investigators compare the results of intervention group with conventionally treated control group (age and sex matched patient who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy).

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ABO compatible and T-flow negative transplants
  • Living kidney transplantation
  • Tacrolimus based immunosuppression

排除标准

  • Multiorgan transplantation
  • Zero-mismatch transplantation (we use cyclosporine instead of FK506)

研究组 & 干预措施

No basiliximab group

Experimental

The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.

干预措施: No basiliximab (Drug)

No basiliximab group

Experimental

The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.

干预措施: Kidney transplantation (Procedure)

Basilixiab group

Active Comparator

Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)

干预措施: Basiliximab (Drug)

Basilixiab group

Active Comparator

Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)

干预措施: Kidney transplantation (Procedure)

结局指标

主要结局

Incidence of rejection

时间窗: within 3 years

The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.

次要结局

  • Incidence of infection(postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Su-Kil Park

Professor

Asan Medical Center

研究点 (1)

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