EUCTR2011-005238-21-DE
进行中（未招募）
1 期
12 month, multi-center, open-label, prospective, randomized, parallel group study investigating a standard regimen in de novo kidney transplant patients versus a Certican® based regimen either in combination with Cyclosporin A or Tacrolimus - ATHENA
ovartis Pharma GmbH0 个研究点目标入组 612 人2012年3月20日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Kidney transplantation
- 发起方
- ovartis Pharma GmbH
- 入组人数
- 612
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female renal allograft recipients at least 18 years old
- •2\. Patient who has received a primary or secondary kidney transplant from a deceased or living unrelated\-/related donor
- •3\. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
- •4\. Recipient of a kidney allograft with a cold ischemia time (CIT) \< 30 hours
- •5\. Female patients who are menstruating and capable of becoming pregnant must have a negative pregnancy test prior to study enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •1\. Multi\-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •2\. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •3\. Patients receiving a kidney from a non\-heart beating donor
- •4\. Patients who are recipients of A\-B\-0 incompatible transplants
- •5\. Patients with a current Panel Reactive Antibody (PRA) level of \> 20% (PRA levels within 4 months prior to enrollment) or patients with a positive Luminex test for any antigen of the donor
- •6\. Patients with already existing antibodies against the HLA\-type of the receiving transplant (in the knowledge of the investigator at the time point of transplantation)
- •7\. Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients
- •8\. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half\-lives of enrollment, whichever is longer
- •9\. Patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dL
- •10\. Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
结局指标
主要结局
未指定
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