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临床试验/NL-OMON30348
NL-OMON30348已完成4 期

A twelve-month, multicenter, open-label, randomized study of the safety, tolerability and efficacy of Certican* with Simulect, corticosteroids and two different exposure levels of tacrolimus in de novo renal transplant recipients - NA

PPD0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
36

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Male or female 18-65 years old
  • Primary transplant from cadaveric, living-unrelated or non-HLA identical living related donor
  • Cold Ischemia time <30 h
  • Negative pregnancy test in female
  • Willing and capable to give written informed consent

排除标准

  • Multiple organtransplants
  • Non-heart beating donor
  • Hypercholestrolemia >9,1 mmol/L
  • Leucocytes <3
  • HIV, HBSag or anti HBC AB positive
  • Allergy to one of the drugs
  • Malignancy apart from localised skin tumors
  • Unable to cooperate or communicate with the investigator

研究者

发起方
PPD

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A twelve-month, multicenter, open-label, randomized... | 临床试验