Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
研究概览
简要总结
The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.
详细描述
The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):
Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization
Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day
After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18.0 years
- •Bone age of boys < 15 years, of girls < 13 years
- •Patients 12-24 months after renal transplantation with stable transplant function
- •First or second kidney transplant, living or cadaver kidney donation
- •Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
- •Patients and parents, respectively, have given their written consent after enlightenment (informed consent)
排除标准
- •Irreversible rejection of former transplant within 6 months
- •Highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
- •Anamnestically steroid-resistant rejection of current transplant
- •More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
- •Glomerular filtration rate (GFR) < 40 ml/min/1.73 m² (Schwartz formula) at study entry
- •Acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
- •Suspected insufficient medication compliance
- •Patients receiving a basic immunosuppression other than that prescribed in this protocol
- •Simultaneous therapy with growth hormone after renal transplantation
研究组 & 干预措施
A
Steroid withdrawal
干预措施: methylprednisolone (Drug)
B
continuos Steroid treatment
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
时间窗: 24 months
次要结局
- Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months(24 months)
- Number of patients who were deprived of steroids successfully(24 months)
- Incidence and severity of steroid side effects(24 months)
研究者
Dr. med. Britta Hoecker
Randomized, multicenter trial on steroid withdrawal in pediatric kidney allograft recipients under CsA and MMF
Klinik für Kinder- und Jugendmedizin