Immunophenotyping and Functional Profiles of Peripheral Lymphocytes in Renal Transplant Recipients After T-cell Depletion With Alemtuzumab (Anti-CD52 Monoclonal Antibody)-Potential Implications for Safe Immunosuppressive Minimization
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.
研究概览
简要总结
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.
详细描述
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results.
In phase 2, subjects will be randomized to one of the three following groups:
Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)
Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage.
Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects between ages 18-65 years old of either gender
- •Recipients have an available ABO compatible living donor for transplant
- •Subjects are listed to be a single-organ transplant recipient (kidney only)
- •Subjects have the ability to provide informed consent
排除标准
- •Subjects have panel reactive antibody greater than 35%
- •Subjects have the potential to have a high recurrence rate of their primary renal disease (i.e. Focal Segmental Glomerulonephritis )
- •Subjects who have a history of Hepatitis C
- •Subjects who have had a previous organ transplant
- •Subjects are unable to fully understand the purpose of the study, thereby unable to give a fully informed consent
- •Subjects with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- •Subjects who are pregnant or nursing
- •Subjects who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
研究组 & 干预措施
Phase I: Alemtuzumab
During Phase I Portion: Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care.
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.
时间窗: Pre-transplant, 6months & 12 months post-transplant
Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months \& 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells \& NK cells, naive \& memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.
次要结局
- Donor Specific Hypo-reactivity.(Pre-transplant, 6mo & 12mo post-transplant)
研究者
Lorenzo Gallon
Associate Professor of Medicine & Surgery
Northwestern University