Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients.
试验速览
- 阶段
- 4 期
- 入组人数
- 286
- 试验地点
- 16
- 主要终点
- Renal function at one year post transplantation
研究概览
简要总结
This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).
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 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
- •Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
- •Absence of positive DSA using Luminex®, MFI>1,000
- •Negative cross-match in cytotoxicity
- •Patient without difficulty to understand and communicate with the investigator and his collaborators
- •Patient entitled to Health System benefits or other such benefits.
排除标准
- •Multiple organ transplantation
- •Recipients of a dual kidney transplant
- •Previous renal allograft
- •History of any other transplantation
- •Receiving a graft from a non-heart-beating donor
- •Patient BMI > 35
- •Patients with evidence of severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin > 3 times upper limit of normal) at screening.
- •Significant severe infection, active peptic ulcer and/or difficulty to absorb oral drugs (active upper gastro-intestinal tract malabsorption syndrome)
- •HIV-positive patients, or with an active B or C hepatitis
- •Patients with de novo malignancy prior to transplantation, other than efficiently treated basal or squamous cell carcinoma of the skin.
- •Leucocyte count lower than 2500/mm3
- •Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control.
- •Known allergy or intolerance to basiliximab, tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
- •Participation in a clinical trial or expanded access trial with an investigational drug within 4 weeks prior to enrollment or concomitantly with this study
- •Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
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
Renal function at one year post transplantation
时间窗: 12 months
Renal function at one year post transplantation estimated by the glomerular filtration rate (GFR) using MDRD 4 (Modification Diet in Renal Disease). Crude difference in renal function at one year between groups and the change of renal function between 4 months and one year in each group will be analyzed and compared.
次要结局
- To determine and compare according to randomized group(12 months)