VIP: Vascular Imaging Project. Prospective Randomized Study on the Effect of AUC-monitored Treatment With Steroids Combined With Either a Calcineurin Inhibitor or Mycophenolate Mofetil on the Progression of Subclinical Cardiovascular Disease in Renal Transplant Recipients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)
研究概览
简要总结
This is a prospective randomized study to compare the influence of area under the curve (AUC)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical cardiovascular disease in renal transplant recipients.
Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease.
详细描述
Stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) will be randomized for AUC-monitored withdrawal of either CNI or MMF.
The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness, Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups.
The duration of the study will be 3 years and the target sample size is 100 patients per arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
- •Informed consent
排除标准
- •Calculated creatinine clearance < 30 ml/min
- •Multi-organ recipients
- •Patients with a (historic) panel reactive antibody (PRA) >60%
- •Third renal transplant or more.
- •Patients receiving investigational drugs other than MMF in combination with cyclosporine or tacrolimus
- •Solid malignancy, post-transplant lymphoproliferative disease.
研究组 & 干预措施
1
AUC monitored withdrawal of MMF
干预措施: AUC monitored withdrawal of MMF or CNI (Drug)
2
AUC monitored withdrawal of CNI
干预措施: AUC monitored withdrawal of MMF or CNI (Drug)
结局指标
主要结局
Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)
时间窗: 3 years
次要结局
- Graft function(1 year, 3 years)
- Graft survival (creatinine clearance < 15 ml/min or dialysis)(1 year, 3 years)
- Patient survival(3 years)
- Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance(3 years)
- Incidence of acute rejection(1 year, 3 years)
研究者
J.S.Mourer
MD
Leiden University Medical Center