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临床试验/CTRI/2011/091/000034
CTRI/2011/091/000034已完成4 期

An open-label, randomized, prospective study to evaluate the efficacy and safety of conversion to Sirolimus (Rapacan) based regimen from Calcineurin Inhibitors based regimen in maintenance kidney transplant recipients - Rapacan Trial

Biocon Limited0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • Men and women renal transplant recipients >= 18yrs old
  • ï?· Undergone denovo live donor renal transplantation >= 3 months prior to enrollment
  • ï?· Receiving CNI based regimen after transplantation
  • ï?· Serum creatinine <= 2.5mg/dl and Proteinuria <=800mg/day

排除标准

  • Pregnant, nursing mothers or women of childbearing potential without an effective method of birth control.
  • &#61623; Renal transplant recipients who had episodes of acute rejection, delayed graft failure or signs of graft failure
  • &#61623; Patients suffering from any malignancy requiring immediate surgery, ongoing chemotherapy or radiation
  • &#61623; Patients suffering from any acute systemic infections within 30 days prior to enrollment
  • &#61623; Use of any investigational drug upto 4 weeks prior to enrolling in the study
  • &#61623; Patients requiring second renal transplantation or Multiple organ transplantation
  • &#61623; Patients having any other systemic disease which may aggravate or prevent him to undergo immunosuppression

研究者

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