Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
NCT ID: NCT05452317
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2022-07-14
2023-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Chronic active AMR group
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
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.
Interventions
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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
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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UBC Late Stage (UK) Ltd.
UNKNOWN
CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Songkai Yan
Role: STUDY_DIRECTOR
CSL Behring
Locations
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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
St Louis, Missouri, United States
Countries
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Other Identifiers
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AMR BoD Study
Identifier Type: -
Identifier Source: org_study_id
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