A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Estimated GFR (calculated using the Cockcroft-Gault formula)
研究概览
简要总结
Hypothesis:
- That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.
Aim:
- To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.
Objectives:
- To assess whether B cell depletion affects graft function, acute rejection and complication rates
- To assess whether the T cell response to allotransplantation is impaired by B cell depletion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
- •Patients who have given written informed consent
- •Women of child bearing potential taking adequate contraception.
排除标准
- •Previous other organ transplants lost through acute rejection
- •Patients undergoing antibody incompatible transplantation
- •Patients with other organ transplants
- •Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
- •Patients with white cell count below 4.0x10^9/L.
- •Patients with platelet count below 100x10^9/L
- •Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
- •Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
- •Pregnant or breastfeeding women
- •Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
- •Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
- •Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
- •Women of child bearing potential not willing to take adequate contraception
研究组 & 干预措施
Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
干预措施: Rituximab (Drug)
Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
干预措施: Tacrolimus (Drug)
Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
干预措施: Mycophenylate mofetil (Drug)
Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
干预措施: Hydrocortisone (Drug)
Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
干预措施: Prednisolone (Drug)
Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
干预措施: Tacrolimus (Drug)
Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
干预措施: Mycophenylate mofetil (Drug)
Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
干预措施: Hydrocortisone (Drug)
Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
干预措施: Prednisolone (Drug)
结局指标
主要结局
Estimated GFR (calculated using the Cockcroft-Gault formula)
时间窗: 1 year
次要结局
- Patient Survival(1, 2, 3, 4, 5 years)
- Biopsy proven acute rejection (based on Banff classification)(1, 2, 3, 4, 5 years)
- Allograft survival(1, 2, 3, 4, 5 years)
- Infection rate(1 year)
- Changes in B and T cell repertoire(1 year)
研究者
Nizam Mamode
Consultant Surgeon and Reader in Transplant Surgery
Guy's and St Thomas' NHS Foundation Trust