Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- One-year Graft Survival
研究概览
简要总结
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.
This study will evaluate:
- Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
- Decreased rates of metabolic complications such as post-transplant diabetes,
- The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
详细描述
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American recipient race
- •Solitary cadaveric or living donor renal transplantation
- •Age ≥18years at the time of transplantation
- •Negative pregnancy serum test in females with childbearing potential
排除标准
- •Age < 18 years at the time of transplantation
- •Multi-organ transplant recipient
- •Currently taking steroids
- •White Blood Cell Count < 3,000
- •Platelet count < 100,000
- •Triglycerides >400mg/dL
- •Cholesterol > 350 mg/dL
- •Unwillingness to comply with study procedures
- •Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)
研究组 & 干预措施
Sirolimus, steroid avoidance arm
Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
干预措施: Sirolimus (Drug)
结局指标
主要结局
One-year Graft Survival
时间窗: 12 months
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival
Cumulative One-year Acute Rejection Rates
时间窗: 12 months
To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant
One-year Patient Survival
时间窗: 12 months
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival
次要结局
- Blood Pressure Control(12 months)
- Incidence of Post Transplant Diabetes(12 months)
- Drug-treated Dyslipidemic Syndrome(12 months)
研究者
Akinlolu Ojo
Emeritus Professor of Medicine
University of Michigan