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

Last updated: April 8, 2020
Sponsor: Omeros Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus Nephritis

Nephritis

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT02682407
OMS721-GNP-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years of age at screening and competent to provide informed consent; ForCohort 4 only, participants are of Asian descent

  • Have a diagnosis of one of the following:

  1. IgAN on kidney biopsy

  2. LN, MN and C3 Glomerulopathy including Dense Deposit Disease on kidney biopsy and 24-hour Urine Protein Excretion (UPE) > 1000 mg/24 hours (for Cohort 1 only)

  3. IgAN diagnosis is confirmed by biopsy within 8 years of screening for Asiandescent (for Cohort 4 only)

  • For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hourUPE > 1 g within 6 months prior to Screening or Urine Protein-Creatinine Ratio (uPCR) > 0.75 by spot urine at screening

  • Screening Estimated Glomerular Filtration Rate (eGFR) >= 30 mL/min/1.73 m^2

  • Are on physician-directed, stable, optimized treatment with angiotensin convertingenzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have asystolic blood pressure of < 150 mmHg and a diastolic blood pressure of < 90 mmHg atrest

Exclusion

Exclusion Criteria:

  • Have a hemoglobin less than 9.0 g/dL

  • Have a platelet count =less than 100,000/mm^3

  • Have an absolute neutrophil count <500 cells/mm^3

  • Have an Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) greaterthan 5.0 x the upper limit of normal (ULN)

  • Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior toScreening

  • Have used: belimumab, eculizumab, or rituximab within 6 months prior to Screening

  • Have a history of renal transplant

  • History of human immunodeficiency virus (HIV), evidence of immune suppression, activehepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody

  • Have a malignancy except for adequately treated and cured basal or squamous cell skincancer, curatively treated in situ disease, or other cancer from which the patient hasbeen disease-free for 5 years or more

Study Design

Total Participants: 54
Study Start date:
February 01, 2016
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Omeros Investigational Site

    Chai Wan,
    Hong Kong

    Active - Recruiting

  • Omeros Investigational Site

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Omeros Investigational Site

    Kowloon,
    Hong Kong

    Site Not Available

  • Omeros Investigational Site

    Sha Tin,
    Hong Kong

    Active - Recruiting

  • Omeros Investigational Site

    Denver, Colorado 80230
    United States

    Site Not Available

  • Omeros Investigational Site

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Omeros Investigational Site

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Omeros Investigational Site

    Evergreen Park, Illinois 60805
    United States

    Site Not Available

  • Omeros Investigational Site

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Omeros Investigational Site

    Flushing, New York 11355
    United States

    Site Not Available

  • Omeros Investigational Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Omeros Investigational Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Omeros Investigational Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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