EUCTR2006-001528-38-DE进行中（未招募）不适用
Prevention of skin cancer in high risk patients after conversion a to Sirolimus-based immunosuppressive - PROSKI
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
- •age 18 years and older
- •minimum period of 6 month after renal transplantation
- •stable renal function and a calculated creatinine clearance of at least 40 ml/min
- •written informed consent
- •proteinuria = 800 mg/d at time of enrolment
- •successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current Sirolimus- or Everolimus- intake
- •Instable graft function (creatinine clearance < 40 ml/min)
- •Graft rejection within the 3 previous months
- •Proteinuria > 800 mg/d
- •Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
- •Leucopenia < 2500/nl
- •Thrombocytopenia < 90/nl
- •Pregnancy or breastfeeding
- •Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
- •Known allergy to macrolides
- •Current participation in other studies
- •Refusal to sign informed consent form
- •Neoplasm other than defined as inclusion criteria
- •All contraindications to SRL (see package insert, appendix)
- •Persons who are detained officially or legally to an official institute
研究者
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