Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- Aorta stiffness at one year post-tranplantation
研究概览
简要总结
The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 et 70 years
- •Patient accepting to give a written informed consent
- •Recipients of a first renal allograft (deceased or living, non HLA identical donor with compatible ABO blood type)
- •Randomized in the ADEQUATE study
- •Patients must have at J112 +/- 3 days a stable renal function (MDRD 4) with an absence of DSA since transplantation.
- •Negative T cross-match in cytotoxicity
- •Tolerate a daily dose of MMF at 1g
排除标准
- •Acute rejection during the first months
- •Existence of a BK infection since M3
- •Proteinuria/reatininuria ratio > 1g/g since M3
研究组 & 干预措施
Group A - tacrolimus half-dose
Immunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose.
Drug: Tacrolimus targeted half-dose
干预措施: Tacrolimus targeted half-dose (Drug)
Group B - tacrolimus unchanged dose
Immunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose
干预措施: Tacrolimus targeted plain dose (Drug)
结局指标
主要结局
Aorta stiffness at one year post-tranplantation
时间窗: 12 months
Evaluate the aorta stiffness at 1 year post-renal transplantation and its evolution in patients who received a half reduction of their daily dose of Advagraf ® 4 months after transplantation compared with patients whose dose has not been divided.
次要结局
- Endothelial activation at one year post-tranplantation(12 months)
- Blood pressure(12 months)