Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of functional graft
研究概览
简要总结
An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.
To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.
To evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.
To evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.
Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.
详细描述
Objectives: The objective of this study is to evaluate the safety and efficacy of everolimus (EVL) combined with low dose of Tacrolimus in comparison with Mycophenolate Sodium (MPS) combined with standard dose of Tacrolimus as immunosuppressive therapy for elderly recipients of kidney transplantation.
Comparison between the two study arms of:
Primary Objective:
- Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) < 50 ml/min at the end of first year after transplantation and every year until the fifth year.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All renal (only) male and female recipients aged ≥ 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).
- •Panel Reactive Antibody (PRA) < 30%.
- •Patients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).
排除标准
- •Allergy to any of proposed medications
- •Patients with any active infection including HBV, HCV and HIV.
研究组 & 干预措施
Everolimus
Number of patients: 45 Everolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml.
Tacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter.
Corticosteroids: as clinical practice.
干预措施: Everolimus (Drug)
结局指标
主要结局
Evaluation of functional graft
时间窗: The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year.
Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) \< 50 ml/min at the end of first year after transplantation and every year until the fifth year.
次要结局
- Pharmacokinetic of Tacrolimus(Days: 7, 30, 60, 67, 90, 180.)
- Serious adverse events(Every year, for five years)
- Bone density(Month 12)
- Quality of Life(Months: 1, 12, 18, 24, 36, 48, 60.)
- Left Ventricular Mass (LVM)(Month: 12.)
- Pharmacokinetic of Everolimus(Days: 7, 30, 60, 67, 90, 180.)
- Pharmacokinetic of Mycophenolate Sodium(Days: 7, 30, 60, 67, 90, 180.)
- Gonadal function(Months: 1, 12.)
- Renal filtration markers(Days: 7, 30, 37, 60, 67, 90, 180. Months: 12, 18, 24, 36, 48, 60)
- Vitamin D(Months: 2, 12.)
- Left Ventricle Ejection Fraction (LVEF)(Month: 12.)
- Biopsy(Every year, for five years)