DRKS00000858进行中（未招募）3 期
Prospective Institutional review trial to test de novo sirolimus monotherapy following antithmocyte globin induction in kidney transplant recipients
niversitätsklinikum FreiburgKlinik für Allgemein und Vizeralchirurgie0 个研究点目标入组 5 人开始时间: 2012年4月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •first kidney transplantation
- •- ager 18 - 65 years
- •- Written informed consent
- •- Highly effective contraception
排除标准
- •- slave- or multi-transplantation
- •- combined transplantation
- •- age < 18 years
- •- incompatibility (allergy, intolerance, oversensitive) against study medication
- •- current malignant disease or last malignant disease< 5 years
- •- Serious intercurrent infections (uncontrolled or requiring treatment (incl. HIV)
- •- severe diarrhoea, vomiting or active gastric- or duodenal ulcer
- •- participation in another investigational sudy
- •- autoimmune disease as primary disease (collagen vascular diseases, colitis, HUS, SLE)
- •- primary disease focal-sclerotising glomerulonephritis
- •- disease, which need temporary or permanent treatment with cortisone (also inhalatory medicines)
- •-severe fat metabolic disturbance (cholesterine > 300 mg/dl, triglycerides > 400 mg/dl)
- •- Epstein-Barr-virus IgG negative
- •- chronic hepatitis B and hepatitis C infection
- •- thrombocytopenia < 50.000 tsd/µl
- •-coagulopathies ( lack of or a defect in v. Willebrand factor, hemophilia, lack of protein S lack of protein C )
研究者
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