Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- PAXGene,
研究概览
简要总结
Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18-80 year old
- •Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)
- •BMI over 30
- •Recipients with pre formed human leukocyte antigens (HLA) antibodies
- •Recipients with donor specific antibodies
- •Recipients who have undergone blood type incompatible transplantation (ABO incompatible)
- •Recipients who have had prior kidney transplants.
排除标准
- •Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)
- •Contraindication to renal biopsy
- •Refusing biopsy
- •Kidney transplant recipient that is a monozygotic twin to the donor
- •When more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)
结局指标
主要结局
PAXGene,
时间窗: 1 PAXgene tube will be collected 3 months post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
PAXGene
时间窗: 1 PAXgene tube will be collected one year post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
AlloSure value change
时间窗: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
Examine if AlloSure predicts the incidence of active, chronic Active antibody mediated rejection (cAMR) and cellular rejection in high risk patients. This will be assessed through observing the changes in AlloSure values one draw after another.
次要结局
- Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)(post-operation day 1)
- Exploring the association between CYP expression and dd-cfDNA(post-operation month 6)