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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

Tracking Information
First Submitted Date  ICMJE February 10, 2016
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date April 10, 2020
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE). [ Time Frame: up to 104 weeks ]
  • Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs. [ Time Frame: 38 weeks ]
  • Cohort 4: Change from baseline in serum and urine complement component levels. [ Time Frame: 38 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Safety as assessed by the incidence of adverse events up until the last visit at Week 18. [ Time Frame: 18 weeks ]
Assess the safety and tolerability of OMS721 in steroid-dependent subjects with IgAN, lupus nephritis, MN, and C3G.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • Cohort 1-3: Change from baseline in serum narsoplimab concentrations. [ Time Frame: up to 104 weeks ]
  • Cohort 4: Change from baseline in serum narsoplimab concentrations. [ Time Frame: 38 weeks ]
  • Cohort1-3: Change from baseline in proteinuria. [ Time Frame: up to 104 weeks ]
  • Cohort1-3: Change from baseline in urine albumin/creatinine ratio. [ Time Frame: up to 104 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • IgAN
  • Lupus Nephritis
  • MN
  • C3 Glomerulopathy
Intervention  ICMJE Biological: OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)
Other Name: narsoplimab
Study Arms  ICMJE Experimental: OMS721 (narsoplimab)
Administration of OMS721 (narsoplimab)
Intervention: Biological: OMS721 (narsoplimab)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2020)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
16
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Omeros Clinical Trial Information 206-676-5000 ctinfo@omeros.com
Listed Location Countries  ICMJE Hong Kong,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682407
Other Study ID Numbers  ICMJE OMS721-GNP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Omeros Corporation
Study Sponsor  ICMJE Omeros Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Omeros Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP