The OPTIMIzE study;OPen label multicenter randomized Trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients.
概览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 7
- 主要终点
- Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24
概览
简要总结
The overall primary study endpoint “successful transplantation” as defined for the individual strata and analyzed for the whole study population. Stratum A: Primary endpoint: successful transplantation at two years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min/1.73m2. Stratum B: Primary endpoint: successful transplantation at two years after transplantation defined as absence of graft or patient loss in the presence of an eGFR above 45 ml/min/1.73m2.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Male or female subject ≥65 years old
- •Subject randomized within 24 hours of completion of transplant surgery
- •Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older
- •Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age
排除标准
- •Subject is a multi-organ transplant recipient
- •Subject with severe systemic infections, current or within the two weeks prior to randomization
- •Subject with severe restrictive or obstructive pulmonary disorders
- •Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
- •Subject with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3
- •Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
- •Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity
- •Recipient of a kidney with a cold ischaemia time (CIT) >24 hr
- •Recipients of a kidney from an HLA-identical related living donor
- •Known intolerability for one or more of the study drugs
结局指标
主要结局
Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24
Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24
Incidence of treated biopsy-proven rejection (tBPAR)
Incidence of treated biopsy-proven rejection (tBPAR)
Rejection treatment and type of rejection treatment
Rejection treatment and type of rejection treatment
The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis
The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events
The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events
Presence of frailty at 12 and 24 months after transplantation and change in frailty from baseline
Presence of frailty at 12 and 24 months after transplantation and change in frailty from baseline
Presence of markers for immunosenescence at 12 and 24 months and changes from baseline
Presence of markers for immunosenescence at 12 and 24 months and changes from baseline
HRQoL at 0, 12 and 24 months and changes from baseline
HRQoL at 0, 12 and 24 months and changes from baseline
Development of donor-specific anti-HLA antibodies (DSA)
Development of donor-specific anti-HLA antibodies (DSA)
Difference in illness perception at 0, 12 and 24 months and changes from baseline
Difference in illness perception at 0, 12 and 24 months and changes from baseline
Difference in BAASIS at 12 and 24 months
Difference in BAASIS at 12 and 24 months
Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24 months and changes from baseline
Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24 months and changes from baseline
Difference in iBOX predicted outcome at 3, 5 and 7 years
Difference in iBOX predicted outcome at 3, 5 and 7 years
次要结局
未报告次要终点
研究者
S.P. Berger
Scientific
Universitair Medisch Centrum Groningen