EUCTR2004-004884-31-GB进行中（未招募）1 期
An open label, randomized pilot study evaluating the early conversion from calcineurin inhibitors to Rapamune in patients with impaired renal function following kidney transplantation - Sirolimus Switch Study
ewcastle upon Tyne Hospitals NHS Trust0 个研究点目标入组 60 人开始时间: 2007年10月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •i.Male and female patients aged 18 to 75 years.
- •ii.Patients with a calculated creatinine clearance (GFR, Cockcroft & Gault method) of > 40 ml/min and < 60 ml/min.
- •iii.Patients with a deterioration of calculated creatinine clearance (GFR, Cockcroft & Gault method) from 3 to 9 months post renal transplantation.
- •iv.Patients treated with a calcineurin inhibitor, either cyclosporin or tacrolimus for a minimum of 3 months before study entry.
- •v.Patients between 6 – 9 months post renal transplantation.
- •vi.Female patients of childbearing age must have a negative serum pregnancy test and agree to use medically accepted form of contraception for the duration of the study and for 3 months following discontinuation of Rapamune.
- •vii.Able and willing to give written informed consent to participate in the trial and co-operate with the trial requirements
- •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
- •i.Known hypersensitivity to Rapamune and its derivatives.
- •ii.Evidence of active systemic or localized infection.
- •iii.Current use of cimetidine, terfenedine, astemizole, pimozide or azole anti-fungals (medications to be discontinued at least 24 hours before administration of sirolimus).
- •iv.Baseline fasting cholesterol level > 7.8 mmol/L and or triglycerides > 4.6 mmol/L.
- •v.Know or suspected malignancy within 5 years prior to study entry (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin) or a history of PTLD.
- •vi.Use of any investigational drug or treatments within 30 days before study entry.
- •vii.Multiple organ transplants (e.g. kidney-pancreas)
- •viii.History of alcohol or drug abuse.
- •ix.Previous participation in this trial.
- •x.HIV positive patients
- •xi. Patients with proteinuria >800mg/24 hours
研究者
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