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Safety, immunogenic...
Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients
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- Lorant, Tomas, 1975- (author)
- Uppsala universitet,Uppsala University,Transplantationskirurgi
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- Bengtsson, Mats (author)
- Uppsala universitet,Uppsala University,Klinisk immunologi
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- Eich, Torsten, 1972- (author)
- Uppsala universitet,Uppsala University,Klinisk immunologi
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- Eriksson, Britt-Marie, Docent, 1952- (author)
- Uppsala universitet,Uppsala University,Infektionssjukdomar
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- Winstedt, Lena (author)
- Hansa Medical AB, Lund, Sweden
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- Järnum, Sofia (author)
- Hansa Medical AB, Lund, Sweden
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- Stenberg, Yvonne (author)
- Hansa Medical AB, Lund, Sweden
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- Robertson, Anna Karin (author)
- Hansa Medical AB, Lund, Sweden
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- Mosén, Kristina (author)
- Hansa Medical AB, Lund, Sweden
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- Björck, Lars (author)
- Lund University,Lunds universitet,Infektionsmedicin,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Infection Medicine (BMC),Section III,Department of Clinical Sciences, Lund,Faculty of Medicine,Department of Clinical Sciences, Division of Infection Medicine, Lund University, Lund, Sweden
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- Bäckman, Lars (author)
- Uppsala universitet,Uppsala University,Transplantationskirurgi
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- Larsson, Erik (author)
- Uppsala universitet,Uppsala University,Klinisk och experimentell patologi
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- Wood, Kathryn (author)
- Nuffield Department of Surgical Sciences, Oxford University, Oxford, UK
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- Tufveson, Gunnar (author)
- Uppsala universitet,Uppsala University,Transplantationskirurgi
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- Kjellman, Christian (author)
- Hansa Medical AB, Lund, Sweden
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(creator_code:org_t)
- Elsevier BV, 2018
- 2018
- English.
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In: American Journal of Transplantation. - : Elsevier BV. - 1600-6135 .- 1600-6143. ; 18:11, s. 2752-2762
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Abstract
Subject headings
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- Safety, immunogenicity, pharmacokinetics, and efficacy of the IgG-degrading enzyme of Streptococcus pyogenes (IdeS [imlifidase]) were assessed in a single-center, open-label ascending-dose study in highly sensitized patients with chronic kidney disease. Eight patients with cytotoxic PRAs (median cytotoxic PRAs of 64%) at enrollment received 1 or 2 intravenous infusions of IdeS on consecutive days (0.12 mg/kg body weight ×2 [n = 3]; 0.25 mg/kg ×1 [n = 3], or 0.25 mg/kg ×2 [n = 2]). IgG degradation was observed in all subjects after IdeS treatment, with <1% plasma IgG remaining within 48 hours and remaining low up to 7 days. Mean fluorescence intensity values of HLA class I and II reactivity were substantially reduced in all patients, and C1q binding to anti-HLA was abolished. IdeS also cleaved the IgG-type B cell receptor on CD19+ memory B cells. Anti-IdeS antibodies developed 1 week after treatment, peaking at 2 weeks. A few hours after the second IdeS infusion, 1 patient received a deceased donor kidney offer. At enrollment, the patient had a positive serum crossmatch (HLA-B7), detected by complement-dependent cytotoxicity, flow cytometry, and multiplex bead assays. After IdeS infusion (0.12 mg/kg ×2) and when the HLA-incompatible donor (HLA-B7+) kidney was offered, the HLA antibody profile was negative. The kidney was transplanted successfully.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- 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 -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Keyword
- Clinical research/practice
- Clinical trial
- Crossmatch
- Desensitization
- Histocompatibility
- Kidney transplantation/nephrology
- Kidney transplantation: living donor
- Pharmacokinetics/pharmacodynamics
- clinical research/practice
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Lorant, Tomas, 1 ...
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Bengtsson, Mats
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Eich, Torsten, 1 ...
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Eriksson, Britt- ...
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Winstedt, Lena
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Järnum, Sofia
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show more...
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Stenberg, Yvonne
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Robertson, Anna ...
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Mosén, Kristina
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Björck, Lars
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Bäckman, Lars
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Larsson, Erik
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Wood, Kathryn
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Tufveson, Gunnar
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Kjellman, Christ ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Immunology in th ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Urology and Neph ...
- Articles in the publication
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American Journal ...
- By the university
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Lund University
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Uppsala University