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

Completed
Conditions
Antibody-mediated Rejection in Kidney Transplant
Interventions
Other: Non-Chronic active AMR group
Other: 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
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
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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.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non-Chronic active AMR groupNon-Chronic active AMR group-
Chronic active AMR groupChronic active AMR group-
Primary Outcome Measures
NameTimeMethod
Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code5 weeks
Number of sessions received of Haemodialysis/Peritoneal Dialysis5 weeks
Number of patients receiving re-transplantation5 weeks
Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code5 weeks
Duration and extent of Haemodialysis/Peritoneal dialysis per year5 weeks
Number of Treatments administered for chronic active AMR5 weeks
Cost of nephrectomy5 weeks
Cost of Treatment administered for chronic active AMR per year5 weeks
Cost of re-transplantations5 weeks
Number of patients receiving Nephrectomy5 weeks
Number of ICD-10 (ICD-9)/OPCS/HRG codes5 weeks
Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG5 weeks
Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG5 weeks
Cost of re-starting Haemodialysis/Peritoneal dialysis per year5 weeks
Death censored graft loss5 weeks

* eGFR\<15ml/min/1.73m2 for \> 60 days

* Hemodialysis for \> 60 days

* Nephrectomy

* Re-transplant

Decline in eGFR value over time5 weeks
Number of Hospital admissions per year overall5 weeks
Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code5 weeks
Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG5 weeks
Secondary Outcome Measures
NameTimeMethod
Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality5 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

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