An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
研究概览
简要总结
The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.
详细描述
Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient younger than 18 but not younger than 2 years of age
- •Skeletal age of boys < or = 17, girls < or = 15 years
- •Patient has end stage kidney disease
- •Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter.
- •The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent
排除标准
- •Patient has a most recently measured panel reactive antibody (PRA) grade of > or = 50%
- •Patient is allergic to or intolerant of study medication
- •Patient and/or donor is known to be HIV positive.
- •Patient has significant liver disease
- •Patient with malignancy or history of malignancy
- •Patient has previously received or is receiving an organ transplant other than kidney.
- •Patient has been previously enrolled in this study.
- •Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.
研究组 & 干预措施
1
干预措施: steroids (Drug)
1
干预措施: tacrolimus (Drug)
1
干预措施: mycophenolate mofetil (Drug)
2
干预措施: tacrolimus (Drug)
2
干预措施: mycophenolate mofetil (Drug)
2
干预措施: daclizumab (Drug)
结局指标
主要结局
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
时间窗: 6 months
次要结局
- Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria(6 months)