Controlled Trial of Induction Therapy in Renal Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction
研究概览
简要总结
Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.
Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
详细描述
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.
Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1 receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg (if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year intervals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 20 Years（Child, 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
Induction
subjects receiving hOKT3 induction therapy
干预措施: hOKT3 (Drug)
Induction
subjects receiving hOKT3 induction therapy
干预措施: Oral Cyclosporine (Drug)
Induction Free Therapy
Patients not receiving induction therapy
干预措施: Oral Cyclosporine (Drug)
Induction Free Therapy
Patients not receiving induction therapy
干预措施: IV Cyclosporine (Drug)
结局指标
主要结局
To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction
时间窗: At 1 year
To compare the efficacy of Sandimmune and Neoral with respect to graft function
时间窗: Throughout study
次要结局
- Length and frequency of hospitalization(Throughout study)
- Nature of "heightened immune response" of younger children by studying gene expression in surveillance biopsies(Throughout study)
- Safety with respect to viral infections and malignancies in children undergoing a renal transplant(Throughout study)
- Correlate intragraft events during rejection with cytokine profile in the peripheral blood(Throughout study)
- Two and four-year graft functions(At 2 and 4 years)
- Frequency and severity of rejection episodes(Throughout study)
- Time to first rejection(Throughout study)
- Nature of acute cellular rejection at a molecular level(Throughout study)