A Retrospective, Chart Review Study to Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
研究概览
简要总结
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Chronic Active AMR group:
- •18 Years and older
- •Recipient of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018]
- •Chronic active AMR diagnosed via kidney biopsy based upon Banff criteria. Patients who additionally have diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology.
- •DSA antibodies within prior 6 months of the biopsy which confirmed chronic active AMR
- •Minimum of 3 years of follow up data following diagnosis of chronic active AMR (unless patient had died)
- •eGFR at time of diagnosis of chronic active AMR of >25ml/min/1.73m2
- •Non-Chronic active AMR group:
- •Age 18 years or older
- •Recipient of ABO compatible solitary kidney transplant between [1 Jan 2013] and [1Jan2018]
- •No documented diagnosis of chronic active AMR during the data extraction period. Patients with other diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible. Patients may or may not have had biopsies.
- •Minimum of 4 years of follow up data since transplant (unless patient has died)
- •eGFR of >25ml/min/1.73m2 at time of matching
排除标准
- •Chronic active AMR group:
- •Recipient of a multi-organ transplant
- •ABO-incompatible transplant
- •Patient lost to follow up within the first 3 years post-diagnosis of chronic active AMR and whose allograft status (graft failure or patient death) is unknown.
- •Non-Chronic active AMR group:
- •Recipient of a multi-organ transplant
- •ABO-incompatible transplant
- •Patient lost to follow up within the first 4 years of transplant and whose allograft status (graft failure or patient death) is unknown.
结局指标
主要结局
Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
时间窗: 5 weeks
Number of sessions received of Haemodialysis/Peritoneal Dialysis
时间窗: 5 weeks
Number of patients receiving re-transplantation
时间窗: 5 weeks
Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
时间窗: 5 weeks
Duration and extent of Haemodialysis/Peritoneal dialysis per year
时间窗: 5 weeks
Number of Treatments administered for chronic active AMR
时间窗: 5 weeks
Cost of nephrectomy
时间窗: 5 weeks
Number of patients receiving Nephrectomy
时间窗: 5 weeks
Number of ICD-10 (ICD-9)/OPCS/HRG codes
时间窗: 5 weeks
Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG
时间窗: 5 weeks
Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG
时间窗: 5 weeks
Cost of re-starting Haemodialysis/Peritoneal dialysis per year
时间窗: 5 weeks
Death censored graft loss
时间窗: 5 weeks
* eGFR\<15ml/min/1.73m2 for \> 60 days * Hemodialysis for \> 60 days * Nephrectomy * Re-transplant
Decline in eGFR value over time
时间窗: 5 weeks
Number of Hospital admissions per year overall
时间窗: 5 weeks
Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code
时间窗: 5 weeks
Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG
时间窗: 5 weeks
Cost of Treatment administered for chronic active AMR per year
时间窗: 5 weeks
Cost of re-transplantations
时间窗: 5 weeks
次要结局
- Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality(5 months)