Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02682407 |
Date of registration:
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10/02/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
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Scientific title:
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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 |
Date of first enrolment:
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February 2016 |
Target sample size:
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54 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02682407 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Hong Kong
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United States
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Contacts
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Name:
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Omeros Clinical Trial Information |
Address:
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Telephone:
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206-676-5000 |
Email:
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ctinfo@omeros.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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MN
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C3 Glomerulopathy
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IgAN
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Lupus Nephritis
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Intervention(s)
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Biological: OMS721 (narsoplimab)
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Primary Outcome(s)
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Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.
[Time Frame: 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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Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).
[Time Frame: up to 104 weeks]
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Secondary Outcome(s)
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Cohort 1-3: Change from baseline in serum narsoplimab concentrations.
[Time Frame: 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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Cohort1-3: Change from baseline in proteinuria.
[Time Frame: up to 104 weeks]
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Cohort1-3: Change from baseline in urine albumin/creatinine ratio.
[Time Frame: up to 104 weeks]
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Secondary ID(s)
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OMS721-GNP-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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