NCT00464399已完成3 期
A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
研究概览
简要总结
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged above 18 years.
- •Patients having received their first or second single renal transplant from deceased or living donor
- •Patient willing and capable of giving written informed consent for study participation
- •Patients treated with as induction therapy at the time of transplantation
- •Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
- •Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
- •Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
排除标准
- •Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
- •Patients with antibodies towards the donor kidney above 30%
- •Patients receiving a renal transplant from HLA-identical sibling
- •Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
- •Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
- •Patients who are recipients of AB0 incompatible transplants
- •Patients with unsuitable laboratory values
- •Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
- •Patient with a current severe major local or systemic infection
- •Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) < 20 ml/min
- •Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
- •Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- •Evidence of severe liver disease
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
次要结局
- Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
- Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
- Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio
研究者
研究点 (1)
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