Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol With Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 37
- 主要终点
- This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection, organ loss and death at 6 months.
研究概览
简要总结
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection.
Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subject or their physician.
Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the transplant.
Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled.
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 living donor renal transplant recipient
- •Age greater than or equal to 18
- •If female and of childbearing potential: a) must not be lactating; b) must have a negative serum B-human chorionic gonadotropin (HCG) test within 24 hours prior to Study Day 0 (Day of Transplant) and; c) must agree to practice an acceptable and reliable form of contraception during the study; and
- •Signed informed consent
排除标准
- •Human Leukocyte Antibody (HLA) identical matched living donor transplant recipient
- •> 2 previous transplants
- •Current panel reactive antibody (PRA) > 20%
- •History of a positive cross-match with the donor
- •Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- •Loss of first kidney transplant in < 1 year
- •History of noncompliance in clinical trial(s)
- •History of chronic CS or immunosuppressive use except for inhaled CS to treat asthma
- •Use of any investigational products during the 90 days prior to screening
- •Requirement for multiple organ transplant
- •Patient without a functioning urinary bladder prior to transplant (e.g. patients with self catheterization will be excluded)
- •Known contraindication to administration of rabbit antithymocyte globulin
- •Currently abusing drugs or alcohol
- •In the opinion of the investigator, at high risk for poor compliance
- •In the opinion of the investigator, has a significant medical or psychosocial problem or unstable disease state that warrants exclusion from the study. Examples of significant problems include, but are not limited to morbid obesity and severe cardiac disease.
结局指标
主要结局
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection, organ loss and death at 6 months.
次要结局
- To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.