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

  • STATUS
    Recruiting
  • participants needed
    54
  • sponsor
    Omeros Corporation
Updated on 18 June 2021
glomerular filtration rate
angiotensin
nephropathy
immunoglobulins
administered intravenously
angiotensin receptor blockers
enzyme inhibitor
mammogram
immunoglobulin a
kidney biopsy
glomerulopathy
lupus nephritis
membranous nephropathy
dense deposit disease
nephritis
complement c3
24-hour urine protein test

Summary

The purpose of this study is to evaluate the safety and tolerability of OMS721 (narsoplimab) in subjects with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 (C3) Glomerulopathy including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of OMS721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of Asian descent with IgA Nephropathy.

Details
Condition Manganese, Mongolia, Monaco, IgA nephropathy, Glomerulonephritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis, Minnesota, C3G, C3 Glomerulopathy
Treatment OMS721, Vehicle (D5W), OMS721 (Narsoplimab)
Clinical Study IdentifierNCT02682407
SponsorOmeros Corporation
Last Modified on18 June 2021

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