TruGraf® Long-term Clinical Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 36
- 主要终点
- occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.
研究概览
简要总结
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
详细描述
Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.
Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent and HIPAA authorization;
- •At least 18 years of age;
- •Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
- •At least 3-months post-transplant;
- •Stable serum creatinine (per Principal Investigator);
- •Treated with any immunosuppressive regimen, and;
- •Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and
排除标准
- •Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
- •Recipient of a previous non-renal solid organ and/or islet cell transplant;
- •Known to be pregnant;
- •Known to be infected with HIV;
- •Known to have Active BK nephropathy;
- •Known to have nephrotic proteinuria (Per Principal Investigator);
- •Participation in other biomarker studies testing clinical utility.
结局指标
主要结局
occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.
时间窗: Baseline to month 24
次要结局
- TruGraf results(Baseline to month 24)
- TRAC results(Baseline to month 24)
- Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)(Baseline to month 24)
- First occurrence of biopsy proven acute rejection (on a for cause biopsy)(Baseline to month 24)
- First occurrence of clinically treated acute rejection(Baseline to month 24)
- Proteinuria(Baseline to month 24)
- Clinical Utility of TruGraf and TRAC in clinical decision making(Baseline to month 24)
- Proportion of subjects with death-censored graft loss(Baseline to month 24)
- Proportion of subjects with graft loss(Baseline to month 24)
- Percent subject death period(Baseline to month 24)
- Subject survival(Baseline to month 24)
- Estimated GFR(Baseline to month 24)
- Graft survival(Baseline to month 24)