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。
研究者
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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