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 个研究点开始时间: 2012年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •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.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
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.
- •2.History of cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma in situ.
- •3.Administration of any investigational drug in the period 0 to 90 days before entry to the study.
- •4.Pregnant or breastfeeding women.
- •5.Patient is scheduled to undergo multiorgan transplantation.
- •6.Chronic or ongoing active infectious disease requiring systemic treatment.
- •7.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria.
- •8.Significant concurrent, uncontrolled medical condition including, but not limited to, hepatic, cerebrovascular, haematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric disease, or evidence of demyelinating disease or concurrent sepsis or active bacterial infection.
- •9.Any other condition which in the principal investigator?s opinion would make patient unsuitable for study participation.
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