CSL Behring AMR BoD study
Research type
Research Study
Full title
A Retrospective, Chart Review Study to Assess Burden of Disease among Kidney Transplant Recipients with Chronic Active Antibody Mediated Rejection.
IRAS ID
314629
Contact name
Songkai Yan
Contact email
Sponsor organisation
CSL Behring LLC.
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
Summary of Research
This is a retrospective, non-interventional study (no drugs or procedures involved) of patients who have undergone a kidney transplant and developed chronic Antibody mediated rejection (AMR) compared with patients who have not. The purpose of the study is to understand healthcare resource utilisation, costs and outcomes associated with the management of patients who have undergone kidney transplantation and developed chronic active AMR compared to those who have undergone kidney transplantation and have not. Another purpose is to assess Major Adverse Cardiac Events (MACE) in patients who have undergone kidney transplantation and developed chronic active AMR compared to those who have not.
This study will take place at around 5 hospitals in the UK, including approx 50 patients. Patients will be consented to the study and their medical charts will be reviewed to collect data for the study. There are no further visits or procedures for patients.
REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0122
Date of REC Opinion
30 May 2022
REC opinion
Further Information Favourable Opinion