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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, Fredrik (författare)
- Linköpings universitet,Linköping University,Tallinn University of Technology,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US,Tallinn Univ Technol, Estonia
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- Szpirt, Wladimir (författare)
- Univ Copenhagen, Dept Nephrol P, Copenhagen, Denmark,University of Copenhagen
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- Kronbichler, Andreas (författare)
- Med Univ Innsbruck, Dept Internal Med Nephrol & Hypertensi 4, Innsbruck, Austria,Medical University of Innsbruck
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- Bruchfeld, Annette (författare)
- Karolinska Institutet,Linköpings universitet,Linköping University,Karolinska University Hospital,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US,Karolinska Univ Hosp, Sweden; CLINTEC Karolinska Inst, Sweden
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- Soveri, Inga (författare)
- Uppsala University,Uppsala universitet,Njurmedicin,Uppsala Univ, Sweden
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- Rostaing, Lionel (författare)
- EriCHU Grenoble Alpes, Dept Nephrol Hemodialysis Apheresis & Kidney Tran, Grenoble, France
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- Daugas, Eric (författare)
- Univ Paris, Hop Bichat, Nephrol Serv, Paris, France,Paris Diderot University
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- Lionet, Arnaud (författare)
- Lille Univ, Ctr Hosp Reg, Neohrol Serv, Lille, France,University of Lille
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- Kamar, Nassim (författare)
- Univ Paul Sabatier, Dept Nephrol & Organ Transplantat, Toulouse, France,Université Paul Sabatier
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- Rafat, Cedric (författare)
- Urgences Nephrolog & Transplantat Renale, Paris, France
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- Myslivecek, Marek (författare)
- Charles Univ Prague, Dept Nephrol, Prague, Czech Republic.;Gen Univ Hosp, Dept Nephrol, Prague, Czech Republic,General University Hospital in Prague
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- Tesar, Vladimir (författare)
- Charles Univ Prague, Dept Nephrol, Prague, Czech Republic.;Gen Univ Hosp, Dept Nephrol, Prague, Czech Republic,General University Hospital in Prague
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- Fernström, Anders, 1958- (författare)
- Linköpings universitet,Linköping University,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US
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- Kjellman, Christian (författare)
- Hansa Biopharma, Lund, Sweden
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- Elfving, Charlotte (författare)
- Hansa Biopharma, Lund, Sweden
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- McAdoo, Stephen (författare)
- Imperial Coll London, Dept Med, London, England,Imperial College London
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- Molne, Johan (författare)
- University of Gothenburg,Univ Gothenburg, Sweden
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- Bajema, Ingeborg (författare)
- Leiden Univ, Med Ctr, Dept Pathol, Leiden, Netherlands,Leiden University Medical Centre
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- Sonesson, Elisabeth (författare)
- Hansa Biopharma, Lund, Sweden
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- Segelmark, Marten (författare)
- Linköpings universitet,Linköping University,Lund University,Lunds universitet,Njurmedicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Nephrology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Avdelningen för diagnostik och specialistmedicin,Region Östergötland, Njurmedicinska kliniken US,Lund Univ, Sweden
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(creator_code:org_t)
- AMER SOC NEPHROLOGY, 2022
- 2022
- Engelska.
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Ingår i: Journal of the American Society of Nephrology. - : AMER SOC NEPHROLOGY. - 1046-6673 .- 1533-3450. ; 33:4, s. 829-838
- Relaterad länk:
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http://dx.doi.org/10...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Nyckelord
- anti-GBM disease
- endopeptidases
- clinical trial
- glomerulonephritis
- Goodpasture syndrome
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Uhlin, Fredrik
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Szpirt, Wladimir
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Kronbichler, And ...
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Bruchfeld, Annet ...
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Soveri, Inga
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Rostaing, Lionel
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visa fler...
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Daugas, Eric
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Lionet, Arnaud
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Kamar, Nassim
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Rafat, Cedric
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Myslivecek, Mare ...
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Tesar, Vladimir
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Fernström, Ander ...
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Kjellman, Christ ...
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Elfving, Charlot ...
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McAdoo, Stephen
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Molne, Johan
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Bajema, Ingeborg
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Sonesson, Elisab ...
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Segelmark, Marte ...
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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 Klinisk medicin
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och Urologi och njur ...
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Journal of the A ...
- Av lärosätet
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Uppsala universitet
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Lunds universitet
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Linköpings universitet
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Karolinska Institutet