Presentation of Renal Function in Liver Transplant Recipients With Certican Therapy: PROTECT Study A Twelve-month, Multicenter, Randomized, Open-label Study of Safety, Tolerability and Efficacy of Certican-based Regimen Versus Calcineurin Inhibitor-based Regimen in de Novo Liver Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Calculated Glomerular Filtration Rate (cGFR)
研究概览
简要总结
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.
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
- •Males or females 18 - 70 years old
- •Liver transplant recipient (living or deceased donor)
- •Patients in whom an allograft biopsy will not be contraindicated
排除标准
- •Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
- •HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
- •HIV positive patients
- •Patients who are breast feeding
- •Patients with a current severe systemic infection
- •Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
- •Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
- •Patients that have received Simulect prior to this study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
干预措施: basiliximab (Drug)
Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
干预措施: CNI (Drug)
Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
干预措施: everolimus (Drug)
Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
干预措施: basiliximab (Drug)
Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
干预措施: CNI (Drug)
结局指标
主要结局
Calculated Glomerular Filtration Rate (cGFR)
时间窗: Month 11
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
次要结局
- Patient and Graft Survival(Month 11)
- Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death(Month 12 to Month 59 post-baseline)
- Incidence of Renal Deterioration(Baseline, Month 11)
- Incidence of Treated BPAR(Month 11)
- Incidence of Efficacy Failure(Month 11)
- Hepatitis C Virus (HCV) Replication in HCV-positive Patients(Baseline, Month 5)
- Incidence of the Need for a Change in the Immunosuppressive Regimen(Month 11)
- Renal Function (cGFR)(Month 5)