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Endopeptidase Cleav...
Endopeptidase Cleavage of Anti-Glomerular Basement Membrane Antibodies in vivo in Severe Kidney Disease: An Open-Label Phase 2a Study
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Uhlin, F. (author)
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Szpirt, W. (author)
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Kronbichler, A. (author)
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Bruchfeld, A. (author)
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Soveri, I. (author)
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Rostaing, L. (author)
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Daugas, E. (author)
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Lionet, A. (author)
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Kamar, N. (author)
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Rafat, C. (author)
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Myslivecek, M. (author)
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Tesar, V. (author)
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Fernstrom, A. (author)
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Kjellman, C. (author)
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Elfving, C. (author)
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McAdoo, S. (author)
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- Mölne, Johan, 1958 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för laboratoriemedicin,Department of Laboratory Medicine
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Bajema, I. (author)
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Sonesson, E. (author)
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Segelmark, M. (author)
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(creator_code:org_t)
- 2022-04
- 2022
- English.
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In: Journal of the American Society of Nephrology. - : Ovid Technologies (Wolters Kluwer Health). - 1046-6673 .- 1533-3450. ; 33:4, s. 829-838
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- Background The prognosis for kidney survival is poor in patients presenting with circulating anti-glomerular basement membrane (GBM) antibodies and severe kidney injury. It is unknown if treat-ment with an endopeptidase that cleaves circulating and kidney bound IgG can alter the prognosis.& nbsp;Methods An investigator-driven phase 2a one-arm study (EudraCT 2016-004082-39) was performed in 17 hospitals in five European countries. A single dose of 0.25 mg/kg of imlifidase was given to 15 adults with circulating anti-GBM antibodies and an eGFR < 15 ml/min per 1.73m(2). All patients received standard treatment with cyclophosphamide and corticosteroids, but plasma exchange only if autoantibodies rebounded. The primary outcomes were safety and dialysis independency at 6 months.& nbsp;Results At inclusion, ten patients were dialysis dependent and the other five had eGFR levels between 7 and 14 ml/min per 1.73m(2). The median age was 61 years (range 19-77), six were women, and six were also positive for anti-neutrophil cytoplasmic antibodies. Then 6 hours after imlifidase infusion, all patients had anti-GBM antibodies levels below the reference range of a prespecified assay. At 6 months 67% (ten out of 15) were dialysis independent. This is significantly higher compared with 18% (nine out of 50) in a historical control cohort (P < 0.001, Fisher's exact test). Eight serious adverse events (including one death) were reported, none assessed as probably or possibly related to the study drug.& nbsp;Conclusions In this pilot study, the use of imlifidase was associated with a better outcome compared with earlier publications, without major safety issues, but the findings need to be confirmed in a randomized controlled trial.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Keyword
- anti-GBM disease
- endopeptidases
- clinical trial
- glomerulonephritis
- Goodpasture syndrome
- prognostic-significance
- plasma-exchange
- anca
- glomerulonephritis
- specificity
- outcomes
- injury
- ides
- Urology & Nephrology
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Uhlin, F.
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Szpirt, W.
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Kronbichler, A.
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Bruchfeld, A.
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Soveri, I.
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Rostaing, L.
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show more...
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Daugas, E.
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Lionet, A.
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Kamar, N.
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Rafat, C.
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Myslivecek, M.
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Tesar, V.
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Fernstrom, A.
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Kjellman, C.
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Elfving, C.
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McAdoo, S.
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Mölne, Johan, 19 ...
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Bajema, I.
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Sonesson, E.
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Segelmark, M.
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show less...
- 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 Urology and Neph ...
- Articles in the publication
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Journal of the A ...
- By the university
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University of Gothenburg