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
- 1
- 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
研究组 & 干预措施
Intervention
Additionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. If absolute levels of dd-cfDNA are > 50 copies/ml, the patients receive a kidney allograft biopsy. Additionally, kidney allograft biopsies are performed according to standard of care as determined by the treating physicians.
干预措施: Kidney allograft biopsy depending on donor-derived cell-free DNA levels (Procedure)
Control
Additionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. These measurements are not used to guide kidney allograft biopsies. Those are performed according to standard of care as determined by the treating physicians.
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