Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection in Kidney Transplant Recipient with Donor-specific Antibodies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time from study inclusion to diagnosis of antibody-mediated rejection
研究概览
简要总结
Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. This study aims to evaluate if repeated analysis of dd-cfDNA in patients with DSA and kidney allograft biopsy which is triggered by increased levels of dd-cfDNA can lead to early diagnosis of active or chronic active ABMR among these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •patients 18 years or older
- •patients provided written informed consent
- •patients after kidney transplantation
- •functioning kidney allograft, at least after 180 days after last transplantation
- •estimated glomerular filtration rate above 20 ml/min/1.73m^2
- •detection of DSA
排除标准
- •patients younger than 18 years
- •patients unable or did not provide written informed consent
- •pregnant or breastfeeding persons
- •patients with increased bleeding risk
- •patients with multi-organ transplantation
- •patients who underwent kidney allograft biopsy after first detection of DSA
- •biopsy-proven antibody-mediated rejection
- •participation in another interventional clinical trial
结局指标
主要结局
Time from study inclusion to diagnosis of antibody-mediated rejection
时间窗: 12 months after inclusion
Time from study inclusion date to biopsy-proven diagnosis of active or chronic active antibody-mediated rejection
次要结局
- Sensitivity of intraindividual dd-cfDNA changes for detection of ABMR(12 Months)
- Clinical Outcome - estimated glomerular filtration rate (eGFR) 12 Months(12 Months)
- Clinical Outcome - eGFR 24 Months(24 Months)
- Clinical Outcome - Death-censored Graft Failure 24 Months(24 Months)
- Rate of ABMR(12 Months)
- Clinical Outcome - albuminuria 12 Months(12 Months)
- Clinical Outcome - Mortality 24 Months(24 Months)
- Specificity of absolute dd-cfDNA for detection of ABMR(12 Months)
- DSA Levels 0 Months(at inclusion)
- Sensitivity of absolute dd-cfDNA for detection of ABMR(12 Months)
- Receiver operating characteristics (ROC) analysis of absolute dd-cfDNA for detection of ABMR(12 Months)
- Sensitivity of combined dd-cfDNA criterion for detection of ABMR(12 Months)
- Clinical Outcome - Death-censored Graft Failure 12 Months(12 Months)
- DSA Levels 12 Months(12 months)
- Immunosuppressive Regimen(24 months)
- Time from first DSA occurrence to diagnosis of antibody-mediated rejection(12 months after inclusion)
- Clinical Outcome - albuminuria 24 Months(24 Months)
- Clinical Outcome - Mortality 12 Months(12 Months)
- Clinical Outcome - Severe Infection 12 Months(12 Months)
- Clinical Outcome - Severe Infection 24 Months(24 Months)
- Adverse Events of Kidney Transplant Biopsy(12 Months)
- DSA Levels 24 Months(24 months)
研究者
Klemens Budde
Senior Physician, Department of Nephrology and Medical Intensive Care
Charite University, Berlin, Germany