CTRI/2014/07/004772已完成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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,972
- 试验地点
- 5
- 主要终点
- Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR)less than 50 mL/min/1.73m2.
研究概览
简要总结
i] Purpose of the Trial - The purpose of the trial is to demonstrate the efficacy and safety of Everolimus in combination with reduced CNI,compared to MPA and standard CNI, in living donor Renal transplant recepients.
ii] FVFV for India - 03-Mar-2014.
iii] Target Sample Size for India - 150
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
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
- •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.
- •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 /mm
- •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.
结局指标
主要结局
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR)less than 50 mL/min/1.73m2.
时间窗: Month 12 is Primary,Month 24 secondary
次要结局
- 1)Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death(2)Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR less than 50 mL/min/1.73m2)
研究者
研究点 (5)
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