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C5a receptor inhibitor avacopan in immunoglobulin A nephropathy - an open-label pilot study

Bruchfeld, Annette (author)
Karolinska Institutet,Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Njurmedicinska kliniken US,Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden
Magin, Hasan (author)
Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden
Nachman, Patrick (author)
Univ Minnesota, MN USA
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Parikh, Samir (author)
Ohio State Univ, OH 43210 USA
Lafayette, Richard (author)
Stanford Univ, CA 94304 USA
Potarca, Antonia (author)
ChemoCentryx, CA USA
Miao, Shichang (author)
ChemoCentryx, CA USA
Bekker, Pirow (author)
ChemoCentryx, CA USA
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 (creator_code:org_t)
2022-01-24
2022
English.
In: Clinical Kidney Journal. - : Oxford University Press. - 2048-8505 .- 2048-8513. ; 15:5, s. 922-928
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background Improvement of proteinuria as a marker for disease activity is associated with a better renal outcome in immunoglobulin A nephropathy (IgAN). Complement is an effector pathway in IgA-mediated kidney injury. Avacopan, a selective C5a receptor inhibitor, has previously shown efficacy in anti-neutrophil cytoplasmic antibody-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of avacopan in patients with IgAN with persistent proteinuria despite a maximally tolerated dose of renin-angiotensin-aldosterone system blockade. The efficacy evaluation was based on the change in proteinuria. Methods This open-label pilot trial enrolled adult patients with biopsy-proven IgAN, urinary protein:creatinine ratio (UPCR) >1 g/g creatinine and an estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m(2) or >45 mL/min/1.73 m(2) if eGFR has not declined >10 mL/min/1.73 m(2) over the previous 24 weeks. If the UPCR remained at >1 g/g creatinine after an 8-week run-in period, patients started avacopan 30 mg twice daily. The primary efficacy endpoint was the change in the slope of the UPCR from the 8-week run-in period to the slope in the 12-week avacopan dosing period. Results A total of 10 of 15 screened patients entered the run-in period. Seven patients with a UPCR >1 g/g creatinine received avacopan. Six of seven patients had numerical improvement in the UPCR during the avacopan treatment period, three of whom had a numerical improvement of similar to 50% at week 12. At week 24, five of seven patients still showed numerical improvement in the UPCR compared with baseline. The urinary monocyte chemoattractant protein-1:creatinine ratio decreased numerically 30% by week 8, possibly reflecting the anti-inflammatory activity of avacopan. Avacopan was well tolerated. There was one serious adverse event of unstable angina, which was deemed to be unrelated to avacopan. Conclusions This short-term pilot study showed an improvement in the slope of the UPCR, with similar to 50% improvement in three of seven patients with IgAN. Longer avacopan treatment duration may be indicated for maximal benefit.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)

Keyword

avacopan; C5a receptor; C5a receptor inhibitor; complement; IgA nephropathy; proteinuria

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