Session Time: 3:15pm-4:00pm
Presentation Time: 3:30pm-4:00pm
*Purpose: 46 highly sensitized patients received kidney transplants after desensitization with imlifidase (currently under investigation) across four Phase 2 clinical trials, and 6-month safety and efficacy have been presented previously. In this status report, the 2-year data of an ongoing long-term follow-up of these patients is presented. The purpose is to assess patient survival, graft survival, estimated glomerular filtration rate (eGFR), AMR frequency, and presence of donor-specific antibodies (DSA).
*Methods: A long-term follow-up study (17-HMedIdeS-14; NCT 03611621) with planned visits 1, 2 , 3, and 5 years after imlifidase treatment is ongoing, and 2-year data have been collected from 31 patients. Serum sample analyses of DSA were evaluated by LABScreen Single Antigen Bead (IgG) (One Lambda). eGFR was calculated from the serum creatinine concentration.
*Results: Following imlifidase desensitization and kidney transplantation, DSA started to return between 3 and 14 days. In some patients DSA return was associated with AMR. Early AMR (onset during the first month post-transplant) occurred in 28% of the crossmatch positive patients, while another 10% were identified as late AMR of which 5% were subclinical, detected in protocol-initiated biopsies at 6 months. Although several patients still showed high, but declining, levels of DSA (Figure 1) only 1 AMR occurred later than 6 months after transplantation. The patient survival rate as well as the death-censored graft survival rate at 2 years were both 91%. 92% of the patients had satisfactory or good kidney function (≥30 mg/min/1.73m2), and at 2 years, the median eGFR was 61.5 (range 22.4-106.7).
*Conclusions: Despite varying levels of DSA rebound among these imlifidase-desensitized patients, the AMR frequency was comparable with those reported in other studies with less sensitized patients, and only 1 AMR occurred later than 6 months after transplantation. Considering the patient and graft survival rates, imlifidase may be a potential treatment option for highly sensitized patients who are unlikely to access an HLA compatible deceased donor organ.
To cite this abstract in AMA style:Jordan SC, Montgomery RA, Lundgren T, Legendre C, Desai N, Eckerwall G, Laxmyr L, Olsson H, Runström A, Schiött Å, Sjöholm K, Sonesson E, Winstedt L, Lorant T, Kjellman C. Follow Up of Imlifidase (IdeS) Desensitized Kidney Transplant Recipients [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/follow-up-of-imlifidase-ides-desensitized-kidney-transplant-recipients/. Accessed May 7, 2021.
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