Open-label, Randomised Multicentre Study of CAMPATH-1H Versus Basiliximab Induction Treatment and Sirolimus Versus Tacrolimus Maintenance Treatment for the Preservation of Renal Function in Patients Receiving Kidney Transplants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 852
- 试验地点
- 20
- 主要终点
- Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy
研究概览
简要总结
The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.
详细描述
The long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure.
Two possible strategies to do this were tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. All patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the Campath-1H arm).
At six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). Patients were then followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •men or women aged over 18 years
- •recipient of kidney transplant (planned in next 24 hours)
排除标准
- •recipients of multi-organ transplant
- •previous treatment with Campath-1H
- •active infection (including HIV, hepatitis B or C)
- •history of anaphylaxis to humanized monoclonal antibody
- •history of malignancy (except adequately treated non-melanoma skin cancer)
- •loss of kidney transplant within 6 months not due to technical reasons
- •medical history that might limit the individual's ability to take trial treatments for the duration of the study
研究组 & 干预措施
Alemtuzumab/Sirolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
干预措施: Alemtuzumab (Drug)
Alemtuzumab/Sirolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
干预措施: Sirolimus (Drug)
Alemtuzumab/Tacrolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
干预措施: Alemtuzumab (Drug)
Alemtuzumab/Tacrolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
干预措施: Tacrolimus (Drug)
Basiliximab/Tacrolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
干预措施: Basiliximab (Drug)
Basiliximab/Tacrolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
干预措施: Tacrolimus (Drug)
Basiliximab/Sirolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
干预措施: Basiliximab (Drug)
Basiliximab/Sirolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
干预措施: Sirolimus (Drug)
结局指标
主要结局
Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy
时间窗: 6 months post-transplantation
Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))
Graft Function (at 18-months After Randomization to Maintenance Therapy)
时间窗: 2 years post-transplantation
Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.
次要结局
- Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy)(6 months post-transplantation)
- Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy)(2 years post-transplantation)
- Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy)(2 years post-transplantation)
- Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy)(2 years post-transplantation)
- Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy)(6-months post-transplantation)
- Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy)(2 years post-transplantation)