Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chronic active AMR group
|
Other: Chronic active AMR group
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
|
| Non-Chronic active AMR group
|
Other: Non-Chronic active AMR group
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
|
Outcome Measures
Primary Outcome Measures
- 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]
- 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
- Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality [5 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Wales | Cardiff | United Kingdom | ||
| 2 | The Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | ||
| 3 | Manchester University NHS Foundation Trust | Manchester | United Kingdom | ||
| 4 | Nottingham City Hospital | Nottingham | United Kingdom | ||
| 5 | Royal Preston Hospital | Preston | United Kingdom |
Sponsors and Collaborators
- CSL Behring
- UBC Late Stage (UK) Ltd.
Investigators
- Study Director: Songkai Yan, CSL Behring
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMR BoD Study