CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- GFR changes between study group and matched control group
研究概览
简要总结
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
详细描述
The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.
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;
- •Between 3 months and 2 years post-transplant;
- •Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care
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 Human Immunodeficiency Virus (HIV);
- •Known to have active BK nephropathy;
- •Known to have nephrotic proteinuria (per principal investigator); or
- •Participation in other biomarker studies
结局指标
主要结局
GFR changes between study group and matched control group
时间窗: 3 years
Comparison of the slope change in estimated glomerular filtration rate (eGFR), calculated using the MDRD 4-variable equation and CKD-EPI, from baseline to the end of follow-up between study participants and a matched control group.
次要结局
- PROMISE results from baseline to study completion(3 years)
- Comparison of Hospitlizations due to infections in the matched control and study group(3 years)
- Comparison of rejection of matched control and study group(3 years)
- Graft survival at 3 years comparison of matched control vs. study group(3 years)
- Graft loss during study period(3 years)
- Death-censored graft loss(3 years)
- Provider changes during study period(3 years)
- Graft survival at 1-2 years comparison of matched control vs. study group(2 years)
- MRSB(3 years)
- PROMISE and Self efficacy results from baseline to study completion(3 years)
- PROMIS Depression scale from baseline to study completion(3 years)
- Graft survival during study period(3 years)
- Patient death during study period(3 years)