Clinical Trial: Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Assess the safety and tolerability of OMS721 in steroid-dependent subjects with IgAN, lupus nephritis, MN, and C3G.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of the safety of OMS721 on laboratory measures. [ Time Frame: 18 weeks ]
    Safety as assessed by changes in laboratory measures.
  • Assess the effect of OMS721 on proteinuria. [ Time Frame: 18 weeks ]
    Proteinuria as assessed by urine albumin/creatine ratio.


Original Secondary Outcome:

  • Assessment of the safety of OMS721 on laboratory measures. [ Time Frame: 18 weeks ]
    Safety as assessed by changes in laboratory measures.
  • Assess the effect of OMS721 on proteinuria. [ Time Frame: 18 weeks ]
    Proteinuria as assessed by urine albumin/creatine ratio.
  • Assess the need for corticosteroid treatment to maintain stable renal function. [ Time Frame: 18 weeks ]
    Corticosteroid need of the equivalent of 10 mg prednisone or more.


Information By: Omeros Corporation

Dates:
Date Received: February 10, 2016
Date Started: February 2016
Date Completion: January 2018
Last Updated: March 3, 2017
Last Verified: January 2017