Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.
The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recipient of deceased or living donor kidney transplant
- •Age 18-75 years (inclusive)
- •Male or female
- •renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
- •Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
- •Willing and able to provide informed consent for study participation
排除标准
- •Prior solid organ transplant (other than kidney)
- •History of donor-specific antibody
- •History of biopsy-proven acute rejection within 1 year prior to enrollment
- •Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
- •Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
- •Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
- •Subjects receiving belatacept (Nulojix)
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study
研究组 & 干预措施
Everolimus conversion
Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to take everolimus 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects will be weaned off of all other immunosuppression medicines when dialysis starts.
干预措施: Everolimus (Drug)
结局指标
主要结局
Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)
时间窗: 36 months
Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI \>5000 defined as positive
次要结局
- Incidence of Return to Dialysis Dependence(36 months)
研究者
Ashtar Chami
Assistant Professor
Emory University