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

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

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

Study Overview

• Status: Completed
• Conditions: Antibody-mediated Rejection in Kidney Transplant
• Intervention / Treatment: Other: Chronic active AMR group; Other: Non-Chronic active AMR group

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine, Div. of Nephrology
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • The Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recipients of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018].

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

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

Collaborators and Investigators

• Sponsor: CSL Behring
• Collaborators: UBC Late Stage (UK) Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AMR BoD Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No