Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
- Conditions
- Antibody-mediated Rejection in Kidney Transplant
- Interventions
- Other: Non-Chronic active AMR groupOther: Chronic active AMR group
- Registration Number
- NCT05452317
- Lead Sponsor
- CSL Behring
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-Chronic active AMR group Non-Chronic active AMR group - Chronic active AMR group Chronic active AMR group -
- Primary Outcome Measures
Name Time Method Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code 5 weeks Number of sessions received of Haemodialysis/Peritoneal Dialysis 5 weeks Number of patients receiving re-transplantation 5 weeks Number of A&E 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 nephrectomy 5 weeks Cost of Treatment administered for chronic active AMR per year 5 weeks Cost of re-transplantations 5 weeks Number of patients receiving Nephrectomy 5 weeks Number of ICD-10 (ICD-9)/OPCS/HRG codes 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 re-starting Haemodialysis/Peritoneal dialysis per year 5 weeks Death censored graft loss 5 weeks * eGFR\<15ml/min/1.73m2 for \> 60 days
* Hemodialysis for \> 60 days
* Nephrectomy
* Re-transplantDecline in eGFR value over time 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 Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG 5 weeks
- Secondary Outcome Measures
Name Time Method Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality 5 months
Trial Locations
- Locations (3)
University of Maryland School of Medicine, Div. of Nephrology
🇺🇸Baltimore, Maryland, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
The Washington University
🇺🇸Saint Louis, Missouri, United States