EUCTR2015-003288-12-Outside-EU/EEA进行中（未招募）不适用
A Phase III, Randomized, Open-Label, Comparative, Multi-CenterStudy to Assess the Safety and Efficacy of Prograf® (tacrolimus)/MMF, Modified Release (MR) Tacrolimus /MMF and Neoral®(cyclosporine)/MMF in de novo Kidney Transplant
Fujisawa Healthcare, Inc.0 个研究点目标入组 660 人开始时间: 2015年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient has been fully informed and has signed an IRB approved informed
- •consent/authorization form and is willing and able to follow study procedures.
- •2. Patient is a recipient of a primary or retransplanted
- •cadaveric or non-HLA-identical living kidney
- •transplant.
- •3. Patient is age greater or equal to 12 years.
- •4. Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
- •5. Female patients of child bearing potential must have a negative urine or serum
- •pregnancy test within 7 days prior to enrollment or upon hospitalization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 658
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has previously received or is receiving an organ transplant other than a
- •2. Patient has received a kidney transplant from a non-heart beating donor.
- •3. Patient has received an ABO incompatible donor kidney.
- •4. Recipient or donor is known to be seropositive for human immunodeficiency
- •virus (HIV).
- •5. Patient has a current malignancy or a history of malignancy (within the past 5
- •years), except non-metastatic basal or squamous cell carcinoma of the skin that
- •has been treated successfully.
- •6. Patient has significant liver disease, defined as having during the past 28 days
- •continuously elevated AST (SGOT) and/or AL T (SGPT) levels greater than 3
- •times the upper value of the normal range of the investigational site.
- •7. Patient has an uncontrolled concomitant infection or any other unstable medical
- •condition that could interfere with the study objectives.
- •8. Patient is currently taking or has been taking an investigational drug in the 30
- •days prior to transplant.
- •9. Patient is receiving everolimus or enteric coated mycophenolic acid at any time
- •during the study.
- •10. Patient has a known hypersensitivity to tacrolimus, cyc1osporine,
- •mycophenolate mofetil or corticosteroids.
- •11. Patient is pregnant or lactating.
- •12. Patient is unlikely to comply with the visits scheduled in the protocol.
- •13. Patient has any form of substance abuse, psychiatric disorder or a condition that,
- •in the opinion of the investigator, may invalidate communication with the
- •investigator.
- •14. Patient has received a kidney with a cold
- •ischemia time of;::: 36 hours
- •15. Patient has received a kidney transplant
- •from a cadaveric donor;::: 60 years of age
- •16. Patient received IVIG therapy prior to
- •randomization
研究者
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