A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients. The REDUCE Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Percentages of Participants Showing Clinical Benefit by Renal Function Stratification
研究概览
简要总结
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF.
详细描述
A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Minimisation of TAC
Treatment with rTAC+EVR+corticosteroids
干预措施: Minimisation of TAC (Drug)
TAC + MMF + corticosteroids
Treatment with TAC + MMF + corticosteroids
干预措施: TAC + MMF + corticosteroids (Drug)
结局指标
主要结局
Percentages of Participants Showing Clinical Benefit by Renal Function Stratification
时间窗: week 4, week 52.
Clinical benefit is defined as: • an improvement in 1 or 2 ranges of the eGFR, according to MDRD-4 at Week 52 post-transplant in patients with values of 30-\<45 or 45-\<60 mL/min/1.73 m2 in Week 4. or • stabilisation of eGFR in patients with values ≥60 mL/min/1.73 m2 at Week 4 and maintained at Week 52 post-transplant.
次要结局
- Changes in Creatinine Clearance - Cockcroft-Gault Formula(Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant)
- Urine Protein/Creatinine Ratio(Screening visit, week 1,4,18,24, and 52)
- Percentage of Participants With Incidence of Proteinuria(Screening visit, week 1,4,18,24, and 52)
- Severity of Rejection(Throughout study period, approximately 2 years and 2 months)
- Percentages of Participants With HCV-positive and HCV Genotype(approximately 2 years and 2 months)
- Concentration of p-P70S6K(weeks 6,8,12,18,24,36,52 at 0 (Cmin), and 1 (C1h) hrs post-dose.)
- Changes in eGFR Based on the MDRD-4 Formula(Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant)
- eGFR Values(MDRD-4 Formula) According to the MELD Score(Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant)
- Percentage of Participants With Acute Rejection, BPAR, and Treated BPAR(Throughout the study period, approximately 2 years and 2 months)
- Time to Rejection(Throughout study period, approximately 2 years and 2 months)