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

Completed

• Conditions: Antibody-mediated Rejection in Kidney Transplant

• 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

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-07-14
• Status Verified: 2023-04
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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
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-transplant
Decline 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
Cost of Treatment administered for chronic active AMR per year	5 weeks
Cost of re-transplantations	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)

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

University of Maryland School of Medicine, Div. of Nephrology; 🇺🇸 Baltimore, Maryland, United States

The Washington University; 🇺🇸 Saint Louis, Missouri, United States