NCT01595984已完成3 期
Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Evolution of glomerular filtration rate measured by clearance of iohexol
研究概览
简要总结
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.
Renal function will be accurately evaluated by measuring the clearance of iohexol.
The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged between 18 and
- •Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
- •Patient with a maximum PRA <20%.
- •Patient wishing and being able to participate fully to the study, and having given a written consent.
- •Patient covered by a social insurance or beneficiary of such a regime.
- •Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.
排除标准
- •Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
- •Patient with a maximum PRA> 20% twice.
- •Cold ischemic time > 36 hours.
- •Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
- •Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
- •Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
- •Patient with severe systemic infections requiring continued therapy.
- •Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
- •Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
- •Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.
- •Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
- •Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
- •Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
- •Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
- •Patient under guardianship, or any patient protected by law.
研究组 & 干预措施
Everolimus + mycophenolate mofetil
Experimental
干预措施: everolimus + mycophenolate mofetil (Drug)
Cyclosporin + Mycophenolate mofetil
Active Comparator
干预措施: cyclosporin + mycophenolate mofetil (Drug)
结局指标
主要结局
Evolution of glomerular filtration rate measured by clearance of iohexol
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (4)
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