Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Expanded Access
Expanded Access
Approved
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Contacts and Locations
Study Contact
Study Contact
- Name: Omeros Clinical Trial Information
- Phone Number: 206-676-5000
- Email: ctinfo@omeros.com
Study Locations
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Chai Wan, Hong Kong
- Omeros Investigational Site
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Hong Kong, Hong Kong
- Omeros Investigational Site
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Kowloon, Hong Kong
- Omeros Investigational Site
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Shatin, Hong Kong
- Omeros Investigational Site
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Colorado
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Denver, Colorado, United States, 80230
- Omeros Investigational Site
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Georgia
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Augusta, Georgia, United States, 30909
- Omeros Investigational Site
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Lawrenceville, Georgia, United States, 30046
- Omeros Investigational Site
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Illinois
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Evergreen Park, Illinois, United States, 60805
- Omeros Investigational Site
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New Jersey
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Voorhees Township, New Jersey, United States, 08043
- Omeros Investigational Site
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New York
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Flushing, New York, United States, 11355
- Omeros Investigational Site
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Texas
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San Antonio, Texas, United States, 78215
- Omeros Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Omeros Investigational Site
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants may be included in the study only if they meet all of the following criteria:
Have a diagnosis of one of the following:
- IgAN diagnosed on kidney biopsy
- Lupus nephritis diagnosed on kidney biopsy (Cohort 1 only)
- Primary MN diagnosed on kidney biopsy (Cohort 1 only)
- C3 glomerulopathy including Dense Deposit Disease diagnosed on kidney biopsy (Cohort 1 only)
- Biopsy confirmed diagnosis of IgAN within 8 years of screening (Cohort 4 only).
- Have 24-hour urine protein > 1000 mg/24 hours.
- Are age >= 18 years at Screening Visit 1 and (for Cohort 4 only) are of Asian descent.
- Have documented history of 24-hour urine protein > 1 g within 6 months prior to Screening or Urine Protein Creatinine Ratio (uPCR) > 0.75 by spot urine at Screening (Cohort 4 only).
- Have an eGFR > 30 mL/min/1.73 m^2 calculated by the Chronic Kidney Disease Epidemiology (CKD-EPI) equation at Screening (Cohort 4).
- Are on physician-directed, stable, optimized treatment with ACEIs and/or ARBs and have a systolic BP of < 150 mmHg and a diastolic BP of < 90 mmHg at rest.
- If female, are either a) not of childbearing potential (i.e., surgically sterilized or postmenopausal for > 1 year), b) have a negative pregnancy test at Screening and baseline and if sexually active must agree to use 2 medically reliable forms of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4), or c) have a medically sterilized male partner. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception, or a barrier method.
- If male having heterosexual intercourse, are either a) not of reproductive potential or b) if sexually active must agree to use a medically reliable form of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4). Acceptable methods of birth control include spermicide in combination with a barrier method, or subject's female partner is willing to use medically acceptable methods of birth control (intrauterine device, hormonal contraception, or a barrier method).
Exclusion Criteria:
- Have a known hypersensitivity to any constituent of the investigational product.
- Have a hemoglobin < 9.0 g/dL.
- Have a platelet count < 100,000/mm^3.
- Have an absolute neutrophil count < 500 cells/mm^3.
- Have an alanine aminotransferase or aspartate aminotransferase > 5.0 x the upper limit of normal.
- Have systemic manifestations of Henoch-Schonlein purpura (e.g., joint pain, gastrointestinal bleeding, abdominal pain) within 2 years prior to Screening Visit 1.
- Have used belimumab, eculizumab, or rituximab within 6 months of Screening Visit 1.
- Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgAN within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN(Cohort 4 only).
- Have a history of renal transplant.
- History of human immunodeficiency virus, evidence of immune suppression, active hepatitis C virus (HCV) infection (participants with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), hepatitis B virus (HBV) infection (participants with positive HBsAg are excluded. For participants with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).
- Have any significant infection requiring antibiotic treatment at Screening Visit 1.
- 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 subject has been disease-free for >=5 years.
- Have an expectation of survival of less than 24 months.
- If female, are pregnant or breastfeeding.
- Have received any other investigational drug or device or experimental procedures within 30 days of Screening Visit 1.
- Are an employee of Omeros, the investigative site, a study staff member, or their immediate family member.
- Have any condition that the Investigator believes would put the subject at risk from participation.
- For participants in Cohort 4, have received systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Narsoplimab
Administration of Narsoplimab Vehicle: 5% dextrose in water |
Biological: narsoplimab
Other Names:
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Other: Vehicle
Drug: Vehicle (5% dextrose in water)
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Biological: narsoplimab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).
Time Frame: up to 104 weeks
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Proportion of participants with Treatment Related Adverse Events (AE).
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up to 104 weeks
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Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.
Time Frame: 38 weeks
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Proportion of participants with Treatment Related Adverse Events (AE).
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38 weeks
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Cohort 4: Change From Baseline in Serum and Urine Complement Component Levels.
Time Frame: 38 weeks
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Concentrations of urine complement components
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38 weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cohort 1-3: Absolute Change From Baseline in Serum Narsoplimab Concentrations (ng/mL).
Time Frame: up to 104 weeks
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Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
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up to 104 weeks
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Cohort 4: Change From Baseline in Serum Narsoplimab Concentrations.
Time Frame: 38 weeks
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Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
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38 weeks
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Cohort 1-3: Change From Baseline in Urine Protein Excretion (UPE) mg/24hrs.
Time Frame: up to 120 days
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Change from Baseline in Urine Protein Excretion (UPE) in mg/24s up to Day 120
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up to 120 days
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Cohort 1-3: Change From Baseline in Urine Albumin/Creatinine Ratio.
Time Frame: up to 104 weeks
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Change From Baseline in Urine Albumin/Creatinine Ratio (mg/g) in OMS721 subjects at Day 120.
Data was displayed for up to 120 days, because some patients received retreatment afterwards.
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up to 104 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Lafayette RA, Rovin BH, Reich HN, Tumlin JA, Floege J, Barratt J. Safety, Tolerability and Efficacy of Narsoplimab, a Novel MASP-2 Inhibitor for the Treatment of IgA Nephropathy. Kidney Int Rep. 2020 Aug 13;5(11):2032-2041. doi: 10.1016/j.ekir.2020.08.003. eCollection 2020 Nov.
- Kidney Int Rep. 2020 Aug 13;5(11):2032-2041. doi: 10.1016/j.ekir.2020.08.003. eCollection 2020 Nov., PMID: 33163724
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Skin and Connective Tissue Diseases
- Lupus Nephritis
- Glomerulonephritis, IGA
- Glomerulonephritis, Membranous
- narsoplimab
Other Study ID Numbers
Other Study ID Numbers
- OMS721-GNP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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