Antibody-mediated Rejection in Kidney Transplant
Conditions
Brief summary
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
Interventions
OTHERChronic active AMR group
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
OTHERNon-Chronic active AMR group
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
Sponsors
UBC Late Stage (UK) Ltd.
CSL Behring
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost of re-transplantations | 5 weeks | — |
| Number of patients receiving re-transplantation | 5 weeks | — |
| Number of Hospital admissions per year overall | 5 weeks | — |
| Death censored graft loss | 5 weeks | * eGFR\<15ml/min/1.73m2 for \> 60 days * Hemodialysis for \> 60 days * Nephrectomy * Re-transplant |
| Decline in eGFR value over time | 5 weeks | — |
| Number of sessions received of Haemodialysis/Peritoneal Dialysis | 5 weeks | — |
| Number of patients receiving Nephrectomy | 5 weeks | — |
| Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code | 5 weeks | — |
| Number of ICD-10 (ICD-9)/OPCS/HRG codes | 5 weeks | — |
| Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code | 5 weeks | — |
| Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code | 5 weeks | — |
| Duration and extent of Haemodialysis/Peritoneal dialysis per year | 5 weeks | — |
| Number of Treatments administered for chronic active AMR | 5 weeks | — |
| Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG | 5 weeks | — |
| Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG | 5 weeks | — |
| Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG | 5 weeks | — |
| Cost of Treatment administered for chronic active AMR per year | 5 weeks | — |
| Cost of re-starting Haemodialysis/Peritoneal dialysis per year | 5 weeks | — |
| Cost of nephrectomy | 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality | 5 months |
Countries
United States
Outcome results
None listed