IRCT20201230049888N1尚未招募4 期
A post-marketing surveillance for the Evaluation of the safety of TGlobulin25 (manufactured by KBC) for the induction of immunosuppressive therapy in adult kidney transplant candidates
Kawsar biotech company0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
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 years 至 65 years（—）
- 性别
- All
入选标准
- •Kidney transplant candidate patients referred to Abuali sina hospital in shiraz, receiving Tglobulin 25 for induction of immunosuppressive therapy.
- •The age of the transplant recipient should be more than 18 years and less than 65 years, and the donor should be more than 5 years and less than 60 years.
- •Able to understand the study and sign the written informed consent
排除标准
- •History of previous treatment with anti-T cell polyclonal agents
- •Panel-Reactive Antibody (PRA)> 20%
- •Known allergy to rabbit proteins
- •Evidence of malignancy in the past 2 years
- •pregnant or lactating females
- •Patients with serological evidence of HIV, HTLV, HCV, HBV
- •WBC< 2000 and/or Plt< 50000 when receiving Tglobulin 25
- •patients receiving organs other than kidney
- •candidates of second kidney transplant
- •donor Serum creatinine> 4
- •ischemic time> 4 hours
研究者
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