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Kidney Week

Abstract: INFO07-SA

Evaluating the Efficacy and Safety of C5aR Inhibitor Avacopan (CCX168) in Patients with Complement 3 Glomerulopathy: A Randomized, Double Blind, Placebo-Controlled Phase 2 Study

Session Information

  • Informational Posters - III
    November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

Authors

  • Bomback, Andrew S., Columbia University, New York, New York, United States
  • Herlitz, Leal C., Cleveland Clinic , Cleveland, Ohio, United States
  • Potarca, Antonia, ChemoCentryx, Inc, Mountain View, California, United States
  • Staehr, Peter, ChemoCentryx, Inc, Mountain View, California, United States
Description

Background: There is currently no approved treatment for Complement 3 Glomerulopathy (C3G), a rare kidney disease characterized by variable degrees of proteinuria, hematuria, renal insufficiency and hypertension. Excessive activity of the alternative complement pathway is a hallmark of the disease, where patients present with variable changes in serum complement levels, which may include decreased serum C3 levels and elevated levels of the membrane attack complex. C3G is diagnosed by renal biopsy which show C3 deposits in the glomerulus; immunoglobin may also be present but at a much lower intensity. Avacopan, an orally administered C5a receptor antagonist, has shown benefit in human trials of the complement-driven
pathology in ANCA vasculitis and in pharmacological models of glomerulopathy associated with Factor H deficiency. This avacopan offers a potential innovative treatment for C3G by attenuating hyperactivity of the alternative pathway activity. A clinical study design evaluating avacopan in C3G will be discussed (NCT03301467).
Methods: This Phase 2, randomized, placebo-controlled, clinical study is actively enrolling up to 88 patients ≥12 years of age with biopsy-proven C3G. Patients are randomized to receive either avacopan (30 mg BID) or placebo for 26 weeks, and then receive avacopan as part of an open-label extension for another 26 weeks. The primary endpoint is percent change from baseline in the C3G Histologic Index for disease activity. Secondary endpoints include stabilization of disease chronicity, measured by the C3G Histologic Index, change from baseline in estimated glomerular filtration rate, urine protein-to-creatinine ratio (UPCR) and MCP-1:creatinine ratio, as well as in quality of life (EQ-5D-5L and SF-36 v2).
Conclusion: The data from this study will inform on the effects of 26 and 52 weeks of treatment with avacopan on the C3G Histologic Index as assessed by renal biopsy and on reduction in proteinuria as measured by UPCR as compared to placebo.

Funding

  • ChemoCentryx Inc.