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Imlifidase desensit...
Imlifidase desensitization in crossmatch-positive, highly-sensitized kidney transplant recipients : Results of an international phase 2 trial (Highdes)
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Jordan, Stanley C. (författare)
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Legendre, Christophe (författare)
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Desai, Niraj M. (författare)
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- Lorant, Tomas, 1975- (författare)
- Uppsala universitet,Transplantationskirurgi,Hansa Biopharma AB
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- Bengtsson, Mats (författare)
- Uppsala universitet,Klinisk immunologi
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Lonze, Bonnie E. (författare)
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Vo, Ashley A. (författare)
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Runström, Anna (författare)
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Laxmyr, Lena (författare)
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Sjöholm, Kristoffer (författare)
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Schiött, Åsa (författare)
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Sonesson, Elisabeth (författare)
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Wood, Kathryn (författare)
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Winstedt, Lena (författare)
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Kjellman, Christian (författare)
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Montgomery, Robert A. (författare)
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(creator_code:org_t)
- 2021
- 2021
- Engelska.
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Ingår i: Transplantation. - 0041-1337 .- 1534-6080. ; 105:8, s. 1808-1817
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- BACKGROUND: Highly-HLA sensitized patients have limited access to life-saving kidney transplantation due to a paucity of immunologically suitable donors. Imlifidase is a cysteine protease that cleaves IgG leading to a rapid decrease in antibody level and inhibition of IgG-mediated injury. This study investigates the efficacy and safety of imlifidase in converting a positive crossmatch test to negative, allowing highly sensitized patients to be transplanted with a living or deceased donor kidney.METHODS: This open-label, single arm, phase 2 trial conducted at five transplant centers, evaluated the ability of imlifidase to create a negative crossmatch test within 24 hours. Secondary endpoints included post-imlifidase DSA levels compared to pre-dose levels, renal function, and pharmacokinetic/pharmacodynamic profiles. Safety endpoints included adverse events and immunogenicity profile.RESULTS: 89.5% of the transplanted patients demonstrated conversion of baseline positive crossmatch to negative within 24 hours after imlifidase treatment. DSA most often rebounded 3-14 days post-imlifidase dose, with substantial interpatient variability. Patient survival was 100% with graft survival of 88.9% at 6 months. 38.9% had early biopsy proven antibody mediated rejection with onset 2-19 days post-transplantation. Serum IgG levels began to normalize after ~3-7 days post-transplantation. Anti-drug antibody levels were consistent with previous studies. Seven adverse events in six patients were classified as possibly or probably related to treatment and were mild-moderate in severity.CONCLUSIONS: Imlifidase was well tolerated, converted positive crossmatches to negative, and enabled patients with a median cPRA of 99.83% to undergo kidney transplantation resulting in good kidney function and graft survival at 6 months.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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Till lärosätets databas
- Av författaren/redakt...
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Jordan, Stanley ...
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Legendre, Christ ...
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Desai, Niraj M.
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Lorant, Tomas, 1 ...
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Bengtsson, Mats
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Lonze, Bonnie E.
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visa fler...
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Vo, Ashley A.
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Runström, Anna
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Laxmyr, Lena
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Sjöholm, Kristof ...
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Schiött, Åsa
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Sonesson, Elisab ...
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Wood, Kathryn
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Winstedt, Lena
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Kjellman, Christ ...
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Montgomery, Robe ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Medicinska och f ...
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och Immunologi inom ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kirurgi
- Artiklar i publikationen
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Transplantation
- Av lärosätet
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Uppsala universitet