Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Kidney Allograft Fibrosis Assessment
研究概览
简要总结
Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and able to give informed consent.
- •Received a first or repeat cadaveric (including ECD) or living donor renal transplant.
- •Patient has stable graft function, defined as no change of greater than 40% of baseline serum creatinine and no acute rejection during the past month.
- •Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their immunosuppression regimen
排除标准
- •Biopsy proven acute rejection episode that occurred within the past month.
- •Malignancy within the past 3 years, except for non-melanoma skin cancer.
- •Currently enrolled in an investigational drug trial.
- •Woman of child bearing potential not utilizing an effective form of birth control.
- •Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
- •Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
- •WBC < 2,000 cells/mm3
- •Platelets < 75,000 cells/mm3
- •Patients who have received an organ transplant other than a kidney.
- •Patients with a history of biopsy proven FSGS, MPGN, or PGN.
研究组 & 干预措施
Low intensity Tacrolimus
Low tacrolimus, everolimus, and steroids
干预措施: Everolimus (Drug)
Standard of Care
Tacrolimus, mycophenolate mofetil and steroids
干预措施: Standard of Care (Other)
结局指标
主要结局
Kidney Allograft Fibrosis Assessment
时间窗: 1 year
Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen. The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better.
次要结局
- Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)(1 year)
- Adverse Drug Reactions(2 year)
- Kidney Allograft Survival(1 year)
- Percentage of Participants Discontinuing or Modifying Immunosuppressant Use(2 year)
- Infection(2 year)