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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682407
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
IgAN Lupus Nephritis MN C3 Glomerulopathy Biological: OMS721 (narsoplimab) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort 2 and 3 subjects are randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 are non-randomized.
Masking: None (Open Label)
Primary Purpose: Treatment
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 Dense Deposit Disease
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OMS721 (narsoplimab)
Administration of OMS721 (narsoplimab)
 Biological: OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)
Other Name: narsoplimab


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE). [ Time Frame: up to 104 weeks ]
  2. Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs. [ Time Frame: 38 weeks ]
  3. Cohort 4: Change from baseline in serum and urine complement component levels. [ Time Frame: 38 weeks ]

Secondary Outcome Measures :
  1. Cohort 1-3: Change from baseline in serum narsoplimab concentrations. [ Time Frame: up to 104 weeks ]
  2. Cohort 4: Change from baseline in serum narsoplimab concentrations. [ Time Frame: 38 weeks ]
  3. Cohort1-3: Change from baseline in proteinuria. [ Time Frame: up to 104 weeks ]
  4. Cohort1-3: Change from baseline in urine albumin/creatinine ratio. [ Time Frame: up to 104 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age at screening and competent to provide informed consent; For Cohort 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 Asian descent (for Cohort 4 only)
  • For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hour UPE > 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 converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have a systolic blood pressure of < 150 mmHg and a diastolic blood pressure of < 90 mmHg at rest

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) greater than 5.0 x the upper limit of normal (ULN)
  • Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior to Screening
  • 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, active hepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody
  • Have a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for 5 years or more
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682407


Contacts
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Contact: Omeros Clinical Trial Information 206-676-5000 ctinfo@omeros.com

Locations
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United States, Colorado
Omeros Investigational Site Active, not recruiting
Denver, Colorado, United States, 80230
United States, Georgia
Omeros Investigational Site Active, not recruiting
Augusta, Georgia, United States, 30909
Omeros Investigational Site Active, not recruiting
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Omeros Investigational Site Active, not recruiting
Evergreen Park, Illinois, United States, 60805
United States, New Jersey
Omeros Investigational Site Active, not recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Omeros Investigational Site Active, not recruiting
Flushing, New York, United States, 11355
United States, Texas
Omeros Investigational Site Active, not recruiting
San Antonio, Texas, United States, 78215
United States, Wisconsin
Omeros Investigational Site Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Hong Kong
Omeros Investigational Site Recruiting
Chai Wan, Hong Kong
Omeros Investigational Site Recruiting
Hong Kong, Hong Kong
Omeros Investigational Site Not yet recruiting
Kowloon, Hong Kong
Omeros Investigational Site Recruiting
Sha Tin, Hong Kong
Sponsors and Collaborators
Omeros Corporation
More Information
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Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT02682407    
Other Study ID Numbers: OMS721-GNP-001
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omeros Corporation:
IgAN
Lupus Nephritis
MN
C3 Glomerulopathy
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Glomerulonephritis, Membranoproliferative
Kidney Diseases
Urologic Diseases
 Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases