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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 04279naa a2200673 4500 | |
| 001 | oai:gup.ub.gu.se/315246 | |
| 003 | SwePub | |
| 008 | 240528s2022 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://gup.ub.gu.se/publication/3152462 URI |
| 024 | 7 | a https://doi.org/10.1681/asn.20211114602 DOI |
| 040 | a (SwePub)gu | |
| 041 | a eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Uhlin, F.4 aut |
| 245 | 1 0 | a Endopeptidase Cleavage of Anti-Glomerular Basement Membrane Antibodies in vivo in Severe Kidney Disease: An Open-Label Phase 2a Study |
| 264 | c 2022-04 | |
| 264 | 1 | b Ovid Technologies (Wolters Kluwer Health),c 2022 |
| 520 | a 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. | |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Urologi och njurmedicin0 (SwePub)302142 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Urology and Nephrology0 (SwePub)302142 hsv//eng |
| 653 | a anti-GBM disease | |
| 653 | a endopeptidases | |
| 653 | a clinical trial | |
| 653 | a glomerulonephritis | |
| 653 | a Goodpasture syndrome | |
| 653 | a prognostic-significance | |
| 653 | a plasma-exchange | |
| 653 | a anca | |
| 653 | a glomerulonephritis | |
| 653 | a specificity | |
| 653 | a outcomes | |
| 653 | a injury | |
| 653 | a ides | |
| 653 | a Urology & Nephrology | |
| 700 | 1 | a Szpirt, W.4 aut |
| 700 | 1 | a Kronbichler, A.4 aut |
| 700 | 1 | a Bruchfeld, A.4 aut |
| 700 | 1 | a Soveri, I.4 aut |
| 700 | 1 | a Rostaing, L.4 aut |
| 700 | 1 | a Daugas, E.4 aut |
| 700 | 1 | a Lionet, A.4 aut |
| 700 | 1 | a Kamar, N.4 aut |
| 700 | 1 | a Rafat, C.4 aut |
| 700 | 1 | a Myslivecek, M.4 aut |
| 700 | 1 | a Tesar, V.4 aut |
| 700 | 1 | a Fernstrom, A.4 aut |
| 700 | 1 | a Kjellman, C.4 aut |
| 700 | 1 | a Elfving, C.4 aut |
| 700 | 1 | a McAdoo, S.4 aut |
| 700 | 1 | a Mölne, Johan,d 1958u Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för laboratoriemedicin,Department of Laboratory Medicine4 aut0 (Swepub:gu)xmolnj |
| 700 | 1 | a Bajema, I.4 aut |
| 700 | 1 | a Sonesson, E.4 aut |
| 700 | 1 | a Segelmark, M.4 aut |
| 710 | 2 | a Göteborgs universitetb Institutionen för biomedicin, avdelningen för laboratoriemedicin4 org |
| 773 | 0 | t Journal of the American Society of Nephrologyd : Ovid Technologies (Wolters Kluwer Health)g 33:4, s. 829-838q 33:4<829-838x 1046-6673x 1533-3450 |
| 856 | 4 8 | u https://gup.ub.gu.se/publication/315246 |
| 856 | 4 8 | u https://doi.org/10.1681/asn.2021111460 |
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