Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection

Study Overview
=================
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

Official Title
-----------------
A Retrospective, Chart Review Study to Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection in the UK

Conditions
-----------------
Antibody-mediated Rejection in Kidney Transplant

Intervention / Treatment
-----------------
* Other: Chronic active AMR group
* Other: Non-Chronic active AMR group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic active AMR group<br> | Other: Chronic active AMR group<br>* Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.<br>|
| Non-Chronic active AMR group<br> | Other: Non-Chronic active AMR group<br>* Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death censored graft loss | eGFR<15ml/min/1.73m2 for > 60 days Hemodialysis for > 60 days Nephrectomy Re-transplant | 5 weeks | 
| 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 | 
| Number of patients receiving re-transplantation |  | 5 weeks | 
| Number of Hospital admissions per year overall |  | 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 | 
| Cost of re-transplantations |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality |  | 5 months |