Clinical trial NCT05452317: Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibody-mediated Rejection in Kidney Transplant
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
Collaborators: name: UBC Late Stage (UK) Ltd.
First posted: 2022-07-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients of blood group system (ABO) compatible solitary kidney transplant between \[1Jan2013\] and \[1Jan2018\].

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


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.

Primary outcomes:
measure: Death censored graft loss
timeFrame: 5 weeks
measure: Decline in eGFR value over time
timeFrame: 5 weeks
measure: Number of sessions received of Haemodialysis/Peritoneal Dialysis
timeFrame: 5 weeks
measure: Number of patients receiving Nephrectomy
timeFrame: 5 weeks
measure: Number of patients receiving re-transplantation
timeFrame: 5 weeks
measure: Number of Hospital admissions per year overall
timeFrame: 5 weeks
measure: Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code
timeFrame: 5 weeks
measure: Number of ICD-10 (ICD-9)/OPCS/HRG codes
timeFrame: 5 weeks
measure: Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
timeFrame: 5 weeks
measure: Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
timeFrame: 5 weeks
measure: Duration and extent of Haemodialysis/Peritoneal dialysis per year
timeFrame: 5 weeks
measure: Number of Treatments administered for chronic active AMR
timeFrame: 5 weeks
measure: Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG
timeFrame: 5 weeks
measure: Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG
timeFrame: 5 weeks
measure: Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG
timeFrame: 5 weeks
measure: Cost of Treatment administered for chronic active AMR per year
timeFrame: 5 weeks
measure: Cost of re-starting Haemodialysis/Peritoneal dialysis per year
timeFrame: 5 weeks
measure: Cost of nephrectomy
timeFrame: 5 weeks
measure: Cost of re-transplantations
timeFrame: 5 weeks
Secondary outcomes:
measure: Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality
timeFrame: 5 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Baltimore
country: United States
facility: University of Maryland School of Medicine, Div. of Nephrology
state: Maryland
city: Saint Louis
country: United States
facility: The Washington University
state: Missouri
Study officials:
affiliation: CSL Behring
name: Songkai Yan
role: STUDY_DIRECTOR
References: