CTI Annual Report 2022 | Page 16

UAB PARTICIPATING IN TRIAL OF PROMISING NEW DESENSITIZATION DRUG

RESEARCH & EDUCATION

RESEARCH & EDUCATION

UAB PARTICIPATING IN TRIAL OF PROMISING NEW DESENSITIZATION DRUG

tends to rule out deceased-donor organs because of the short notice . Pre-treatment of patients with imlifidase can be completed in as little as 24-48 hours . The medication is discontinued upon transplantation , but as with all organ transplants , patients will need to continue taking standard anti-rejection medications for life .
The efficacy of imlifidase will be compared against the present standard of care , which for most patients is to remain on the waiting list hoping for a suitably matched organ . Trial-related follow-up evaluation of the patients will occur after one year .
The study is titled “ Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx ”, and enrollment is expected to conclude in late 2022 . The CTI and at least nine other transplant centers are participating , and the trial is expected to enroll some 64 patients .
As part of the trial , the organ-matching criteria will be adjusted for participants , so that they are considered for a wider range of kidneys , according to Douglas Anderson , MD , an assistant professor of Surgery in the UAB Division of Transplantation .
Some patients who need a kidney transplant have human leukocyte antigen ( HLA ) antibody profiles that make it very hard to match them with a donor organ . In the most extreme cases , highly sensitized patients might only match with less than 0.5 % of kidneys that come available .
The UAB Comprehensive Transplant Institute ( CTI ) is participating in a national , multi-center clinical trial of a medication called imlifidase ( Idefirix ), which is designed to reduce patient sensitivity by breaking up , or “ cleaving ”, certain antibodies . The drug specifically targets IgG and inhibits IgG-mediated immune response . Produced by Hansa Biopharma , imlifidase already is being used in some European countries .
Other desensitization therapies do exist , but typically they require weeks of pre-treatment , which is possible with living-donor organs but
“ When a potentially suitable kidney comes available , we will give the patient the medication and check them again ,” Dr . Anderson says . “ If we find that their antibodies are no longer prohibitive , then we would proceed with the transplant .”
Dr . Anderson says imlifidase could be a game-changer for highly sensitized patients .
“ They already have priority in getting a kidney allocated to them , so if a matching kidney comes up , they are very likely to get it , but the odds of that happening are very , very small . These patients are basically playing the lottery ,” Dr . Anderson says . “ We know that a kidney transplant is superior to dialysis , so the benefit to patients ’ quality of life would be huge .”
14 UAB CTI Report