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The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis

Open access
Jayne, David R.W., Bruchfeld, Annette N., Harper, Lorraine, Schaier, Matthias, Venning, Michael C., Hamilton, Patrick, Burst, Volker, Grundmann, Franziska, Jadoul, Michel, Szombati, István, Tesař, Vladimír, Segelmark, Mårten, Potarca, Antonia, Schall, Thomas J., Bekker, Pirow, for the CLEAR Study Group·2017·Journal of the American Society of Nephrology

Abstract

Alternative C activation is involved in the pathogenesis of ANCA-associated vasculitis. However, glucocorticoids used as treatment contribute to the morbidity and mortality of vasculitis. We determined whether avacopan (CCX168), an orally administered, selective C5a receptor inhibitor, could replace oral glucocorticoids without compromising efficacy. In this randomized, placebo-controlled trial, adults with newly diagnosed or relapsing vasculitis received placebo plus prednisone starting at 60 mg daily (control group), avacopan (30 mg, twice daily) plus reduced-dose prednisone (20 mg daily), or avacopan (30 mg, twice daily) without prednisone. All patients received cyclophosphamide or rituximab. The primary efficacy measure was the proportion of patients achieving a ≥50% reduction in Birmingham Vasculitis Activity Score by week 12 and no worsening in any body system. We enrolled 67 patients, 23 in the control and 22 in each of the avacopan groups. Clinical response at week 12 was achieved in 14 of 20 (70.0%) control patients, 19 of 22 (86.4%) patients in the avacopan plus reduced-dose prednisone group (difference from control 16.4%; two-sided 90% confidence limit, −4.3% to 37.1%; P =0.002 for noninferiority), and 17 of 21 (81.0%) patients in the avacopan without prednisone group (difference from control 11.0%; two-sided 90% confidence limit, −11.0% to 32.9%; P =0.01 for noninferiority). Adverse events occurred in 21 of 23 (91%) control patients, 19 of 22 (86%) patients in the avacopan plus reduced-dose prednisone group, and 21 of 22 (96%) patients in the avacopan without prednisone group. In conclusion, C5a receptor inhibition with avacopan was effective in replacing high-dose glucocorticoids in treating vasculitis.

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Metadata

Authors
Jayne, D. R. W., Bruchfeld, A. N., Harper, L., Schaier, M., Venning, M. C., Hamilton, P., Burst, V., Grundmann, F., Jadoul, M., Szombati, I., Tesař, V., Segelmark, M., Potarca, A., Schall, T. J., Bekker, P., & for the CLEAR Study Group
Venue
Journal of the American Society of Nephrology
Published
2017-04-11
Volume
28
Issue
9
Pages
2756-2767
ISSN
  • 1046-6673 (ISSN-L)
  • 1533-3450
OpenAlex
W2607382700
Cited by
607
References
33
FWCI
47.38
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis. https://app.cochat.ai/papers/10.1681/asn.2016111179
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Jayne, D. R. W., Bruchfeld, A. N., Harper, L., Schaier, M., Venning, M. C., Hamilton, P., Burst, V., Grundmann, F., Jadoul, M., Szombati, I., Tesař, V., Segelmark, M., Potarca, A., Schall, T. J., Bekker, P., & for the CLEAR Study Group. (2017). Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis. Journal of the American Society of Nephrology. https://doi.org/10.1681/asn.2016111179

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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