A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Number of Patients Alive
研究概览
简要总结
The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •First deceased-donor kidney transplantation
- •Age >18 years
- •Donor <65 years
- •Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity
- •panel reactive antibodies (PRA) <10%
- •Written consent
排除标准
- •Retransplantation, combined transplantation
- •Prior immunosuppression less than 6 months prior transplantation
- •Induction therapy with antibodies
- •Leukopenia < 4000, thrombocytopenia < 100 000, Haemoglobin < 80 g/l
- •History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α
- •Tuberculosis history
- •Anti-hepatitis C virus (HCV) positivity, HBsAg
- •HIV positivity
- •Malignancy history
- •Allergy to study medication
- •Fertile women without contraception
- •Pregnancy, breastfeeding mothers
研究组 & 干预措施
Sirolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy.
干预措施: Sirolimus (Drug)
Tacrolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at POD 14, they were randomized to tacrolimus monotherapy.
干预措施: Tacrolimus (Drug)
Sirolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy.
干预措施: MabCampath, (Drug)
Tacrolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at POD 14, they were randomized to tacrolimus monotherapy.
干预措施: MabCampath, (Drug)
Tacrolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at POD 14, they were randomized to tacrolimus monotherapy.
干预措施: Remicade (Drug)
Sirolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy.
干预措施: Remicade (Drug)
Sirolimus
Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Number of Patients Alive
时间窗: 1 year
Number of Patients With Functional Graft
时间窗: 1 year
次要结局
- Number of Participants With Biopsy-proven Subclinical Rejection(1 year)
- Kidney Graft Function (Measured by Serum Creatinine)(1 year)
- Number of Bioptically Verified Rejection Episodes(1 year)
- Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)(1 year)
研究者
Petra Hruba
IKEM
Institute for Clinical and Experimental Medicine