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Trial record 3 of 4 for:    oms721

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

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ClinicalTrials.gov Identifier: NCT02682407
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of OMS721 in subjects with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3 Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (Nab).

Condition or disease Intervention/treatment Phase
IgAN Lupus Nephritis MN C3G Biological: OMS721 Other: Vehicle (D5W) Phase 2

Detailed Description:
This is a Phase 2, multicenter study of OMS721 in subjects with the following diseases: IgA Nephropathy (IgAN), Lupus Nephritis, Membranous Nephropathy (MN), or C3 Glomerulopathy, including Dense Deposit Disease. Three cohorts will be enrolled. Cohort 1 will be subjects with corticosteroid dependent IgAN, LN, MN, or C3 Glomerulopathy. Cohort 1 subjects will all receive OMS721 in an uncontrolled, open-label design. Cohort 2 and 3 will be subjects with IgA nephropathy who are not receiving corticosteroids. These cohorts will be randomized to receive either OMS721 treatment or D5W vehicle in a randomized double-blind design. Approximately 44 subjects will be enrolled (16 in Cohort 1, 10 in Cohort 2, and 18 in Cohort 3).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cohort 2 and 3 will be randomized in a 1:1 fashion during the first 12 weeks of treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 2018
Estimated Study Completion Date : December 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: OMS721
Administration of OMS721.
Biological: OMS721
Biological: OMS721
Vehicle (D5W)
Administration of Vehicle (D5W).
Other: Vehicle (D5W)
5% Dextrose in water


Outcome Measures

Primary Outcome Measures :
  1. Safety as assessed by the incidence of adverse events up until the last visit at Week 104. [ Time Frame: 104 weeks ]
    Assess the safety and tolerability of OMS721 in subjects with IgAN, lupus nephritis, MN, and C3G.


Secondary Outcome Measures :
  1. Assessment of the safety of OMS721 on laboratory measures. [ Time Frame: 104 weeks ]
    Safety as assessed by changes in laboratory measures.

  2. Assess the effect of OMS721 on proteinuria. [ Time Frame: 104 weeks ]
    Proteinuria as assessed by urine albumin/creatine ratio.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Are at least 18 years of age
  • Have a diagnosis of: IgAN, Lupus Nephritis, MN, or C3 Glomerulopathy including Dense Deposit Disease
  • Have 24-hour urine protein > 1000 mg/24 hours
  • For subjects in Cohort 1, have been on ≥ 10 mg of prednisone or equivalent dose for at least 12 weeks prior to Screening
  • If on immunosuppressive treatment (e.g., cyclophosphamide, mycophenolate mofetil), have been on a stable dose for at least 2 months prior to Screening Visit 1 with no expected change in the dose for the study duration
  • eGFR >= 30 mL/min/1.73 m2 calculated by the MDRD equation
  • 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 < 9.0 g/dL
  • Have a platelet count < 100,000/mm3
  • Have an absolute neutrophil count < 500 cells/mm3
  • Have an ALT or AST > 5.0 x the upper limit of normal
  • 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
  • Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at Screening
  • Have any significant infection requiring antibiotic treatment at Screening
  • 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
  • Have an expectation of survival of less than 24 months
  • For subjects in Cohort 2 and Cohort 3, have received corticosteroids within the 3 months prior to screening
  • Subjects in Cohort 1 rolling into Cohort 3 must have IgAN and must have discontinued corticosteroids prior to entry into Cohort 3, but the discontinuation may occur at any time prior to Cohort 3 entry
Contacts and Locations

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
Contact: Soyoung Han 206-676-5000 shan@omeros.com
Contact: Andrea Kessler 206-676-5000 akessler@omeros.com

Locations
United States, Colorado
Omeros Investigational Site Recruiting
Denver, Colorado, United States, 80230
United States, Georgia
Omeros Investigational Site Recruiting
Augusta, Georgia, United States, 30909
United States, Illinois
Omeros Investigational Site Recruiting
Evergreen Park, Illinois, United States, 60805
United States, New Jersey
Omeros Investigational Site Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Omeros Investigational Site Recruiting
Flushing, New York, United States, 11355
United States, Texas
Omeros Investigational Site Recruiting
San Antonio, Texas, United States, 78215
United States, Wisconsin
Omeros Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Steve Whitaker, M.D., J.D. Omeros Corporation
More Information

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT02682407     History of Changes
Other Study ID Numbers: OMS721-GNP-001
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Omeros Corporation:
IgAN
MN
C3 Glomerulopathy
Lupus Nephritis

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Glomerulonephritis, Membranoproliferative
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases