CTRI/2014/07/004772招募中4 期
A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen.
ovartis Healthcare Private Limited0 个研究点目标入组 1,972 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,972
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Written informed consent obtained.
- •2.Subject randomized within 24 hr of completion of transplant surgery.
- •3.Recipient of a kidney with a cold ischemia time < 30 hours.
- •4.Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
排除标准
- •1.Subject unable to tolerate oral medication at time of randomization.
- •2.Use of other investigational drugs at the time of enrollment.
- •3.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •4.Multi-organ transplant recipient.
- •5.Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
- •6.Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
- •7.Subject who is HIV-positive.
- •8.HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels >= 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
- •9.Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
- •10.Subject with a BMI greater than 35.
- •11.Subject with severe systemic infections, current or within the two weeks prior to randomization.
- •12.Subject requiring systemic anticoagulation.
- •13.History of malignancy of any organ system.
- •14.Subject with severe restrictive or obstructive pulmonary disorders.
- •15.Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
- •16.Subject with white blood cell (WBC) count <= 2,000 /mm3 or with platelet count <= 50,000 /mm3.
- •17.Pregnant or nursing (lactating) women.
- •18.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
研究者
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