Phase
Condition
Lupus Nephritis
Nephritis
Kidney Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 18 years of age at screening and competent to provide informed consent; ForCohort 4 only, participants are of Asian descent
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 Asiandescent (for Cohort 4 only)
For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hourUPE > 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 convertingenzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have asystolic blood pressure of < 150 mmHg and a diastolic blood pressure of < 90 mmHg atrest
Exclusion
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) greaterthan 5.0 x the upper limit of normal (ULN)
Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior toScreening
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, activehepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody
Have a malignancy except for adequately treated and cured basal or squamous cell skincancer, curatively treated in situ disease, or other cancer from which the patient hasbeen disease-free for 5 years or more
Study Design
Connect with a study center
Omeros Investigational Site
Chai Wan,
Hong KongActive - Recruiting
Omeros Investigational Site
Hong Kong,
Hong KongActive - Recruiting
Omeros Investigational Site
Kowloon,
Hong KongSite Not Available
Omeros Investigational Site
Sha Tin,
Hong KongActive - Recruiting
Omeros Investigational Site
Denver, Colorado 80230
United StatesSite Not Available
Omeros Investigational Site
Augusta, Georgia 30909
United StatesSite Not Available
Omeros Investigational Site
Lawrenceville, Georgia 30046
United StatesSite Not Available
Omeros Investigational Site
Evergreen Park, Illinois 60805
United StatesSite Not Available
Omeros Investigational Site
Voorhees, New Jersey 08043
United StatesSite Not Available
Omeros Investigational Site
Flushing, New York 11355
United StatesSite Not Available
Omeros Investigational Site
Cincinnati, Ohio 45267
United StatesSite Not Available
Omeros Investigational Site
San Antonio, Texas 78215
United StatesSite Not Available
Omeros Investigational Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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