Comparison Of Efficacy Of Two Immunosuppressive Protocols Including Tacrolimus With Or Without Mycophenolate Mofetil In Pediatric Liver Transplantation Aimed In Early Termination Of Steroid Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of rejections, number of steroid-resistant rejections.
研究概览
简要总结
Open label, randomised, prospective, onecentre Investigator Driven Study:
Comparison of two protocols of immunosuppression after liver Tx in children:
A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30 mg/kg/D p.o. day 0 through day 90.
B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10 mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0 to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone -0,3-0,2 mg/kg/D; Month 4-6 Prednisone 0,2 - 0,1 mg/kg/D Month 7 - Steroid withdrawal FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).
Primary end points:
Number of rejections, number of steroid-resistant rejections.
Secondary end points:
Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal function before Tx and 1 year after Tx
详细描述
A: Study group
FK506-MMF.
Immunosupression protocol:
Metylprednisolon 10 mg/kg intraoperatively i.v.
FK506 Day 0 or 1 oraly (0,15 mg/kg/D in two doses).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all of the following criteria are eligible for this study:
- •Male or female patients, not older than 18 years old.
- •Primary liver transplantation
- •Patient is capable of understanding the purpose and risks of the study and has been informed both orally and in writing and has given informed consent
排除标准
- •Subjects who meet one or more of the following criteria are not eligible for this study:
- •Female patients who are pregnant or are breast feeding
- •Patients > 18 years old
- •Combined liver-kidney transplantation
- •Recipient of second liver graft
- •Patients are allergic, hyper-sensitive or intolerant to HCO-60 or structurally related compounds, macrolide antibiotics or tacrolimus.
- •Patients with known HIV-anamnesis
- •Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for another indication than the prophylaxis of liver graft rejection
- •Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer.
- •Patient is participating or has participated in another clinical study and/or is taking or has been taking an investigational drug in the past 28 days.
- •Other reasons which depend on the assessment of the physician (no MMF will be given to patients with severe persistent hypersplenism (WBC < 3.500/ml, platelets < 50.000/ml)
结局指标
主要结局
Number of rejections, number of steroid-resistant rejections.
次要结局
- Hyperglycemia/Diabetes de novo one year after transplantation
- Dyslipidemia one year after transplantation
- Hypertension one year after transplantation
- Patients and graft survival
- Renal function before Tx and 1 year after Tx