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 : Unknown
Verified April 2020 by Omeros Corporation.
Recruitment status was: Recruiting
First Posted : February 15, 2016
Last Update Posted : April 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IgAN Lupus Nephritis MN C3 Glomerulopathy | Biological: OMS721 (narsoplimab) | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: OMS721 (narsoplimab)
Administration of OMS721 (narsoplimab)
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Biological: OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)
Other Name: narsoplimab |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Have a diagnosis of one of the following:
- IgAN on kidney biopsy
- 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)
- 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

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
Contact: Omeros Clinical Trial Information | 206-676-5000 | ctinfo@omeros.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
IgAN Lupus Nephritis MN C3 Glomerulopathy |
Nephritis Lupus Nephritis Glomerulonephritis, Membranoproliferative Kidney Diseases Urologic Diseases |
Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |