CTRI/2012/02/002441进行中（未招募）4 期
A 12-month, multicenter, randomized, comparative, open-label study to investigate efficacy & safety of reduced level of TACrolimus with equimolar MyforTIC (Enteric coated Mycophenolate Sodium) or Mycophenolate Mofetil in de novo renal transplant recipients. - myTACTIC
ovartis Healthcare Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •1. Male or female de novo renal transplant recipients between 18 and 70 years of age.
- •2. Patients who are receiving a primary cadaveric donor or non-HLA identical living donor kidney transplant (liver related haplograft).
- •3. Patients who have given written informed consent to participate in the study.
- •4. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and willing to use an effective means of contraception for the total study duration.
排除标准
- •1. Patients who are recipients of multiple solid organ or tissue transplants (dual kidney is allowed), or have previously received an organ or tissue transplant.
- •2. Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant.
- •3. Patients with platelet count 100,000/mm at the evaluation before randomization.
- •4. Patients with an absolute neutrophil count of 1,500/mm³ at baseline before surgery or white blood cell count of 4,500/mm³, or leukocytopenia ( 2,500/mm3), or hemoglobin 6g/dL prior to randomization.
- •5. Renal cold ischemic time (CIT) 30 hours.
- •6. Patients with a known hypersensitivity to either study drugs or their class, or to any of excipients
- •7. Patients with clinically significant systemic infection at time of transplant or within two weeks of transplant.
- •8. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter absorption, distribution, metabolism and excretion of study medication.
- •9. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (-HCG) at Screen.
- •10. Patient is of childbearing potential (men and women) and unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception.
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