跳至主要内容
临床试验/EUCTR2011-004223-12-ES
EUCTR2011-004223-12-ES
进行中(未招募)
不适用

A pilot, randomised, double blind, placebo-controlled, parallel groups, clinical trial to investigate the efficacy and safety of Cardiotrophin-1 (CT-1) in kidney transplantation.

Digna Biotech S.L.0 个研究点2012年7月26日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Kidney transplantation.
发起方
Digna Biotech S.L.
状态
进行中(未招募)
最后更新
11年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2012年7月26日
结束日期
待定
最后更新
11年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
Digna Biotech S.L.

入排标准

入选标准

  • A donor will be suitable only if all of the following criteria apply:
  • 1\.Heart\-beating donors (male or female);
  • 2\.Donor aged ? 60 or donor aged 50\-59 years and fulfilling 2 of the following 3 criteria:
  • a.Serum creatinine more than 1\.5 mg/dl.
  • b.Death due to cerebrovascular accident.
  • c.History of high blood pressure.
  • A patient (Kidney recipient) will be eligible only if all of the following criteria apply:
  • 1\.Males or females aged 18 to 70 years without restricted legal competence and being able to comply with the study requirements.
  • 2\.Females of Childbearing Potential must have a negative urine pregnancy test at Screening/Treatment visit and must be willing to use one medically approved form of birth control while on study and for at least 28 days after taking kidney transplant.
  • 3\.Subject capable of giving written informed consent.

排除标准

  • A donor will not be suitable if any of the following criteria apply:
  • 1\.Infection by HIV, HBV and/or HCV viruses.
  • 2\.Non\-heart beating donors.
  • 3\.Kidney from a living donor.
  • 4\.Cold ischemic time \>24 hours.
  • 5\.Incompatible AB0 type with recipient.
  • 6\.Positive crossmatch with recipient.
  • 7\.Kidney maintained by pulsatile machine perfusion.
  • A patient (recipient) will not be eligible if any of the following criteria apply:
  • 1\.Previous or current myelodysplastic or proliferative disorders.

结局指标

主要结局

未指定

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