OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 434

Inclusion Criteria

•Age 18 years or older at the onset of Screening
•Biopsy confirmed diagnosis of IgAN within 10 years prior to Screening
•Proteinuria of > 1 g in 24-hour urine collection at Screening and baseline
•Estimated glomerular filtration rate of = 30 and = 90 mL/min/1.73 m2 at Screening and baseline
•Currently on physician-directed, stable treatment with RAS blockade (ACEIs, ARBs, direct renin inhibitors) and have a systolic BP of < 150 mmHg and a diastolic BP of < 100 mmHg at rest
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

•Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to Screening
•Unwilling or unable to discontinue systemic corticosteroids 12 weeks prior to Randomization
•Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments
•Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch Schonlein purpura), secondary IgAN, or other renal disease
•Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening
•History of renal transplantation
•Have a known hypersensitivity to any constituent of the investigational product
•Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m2 within 24 weeks or > 15 mL/min/1.73 m2 within 3 months prior to Screening
•Significant abnormalities in clinical laboratory values
•Body mass index = 35 kg/m²
•History of human immunodeficiency virus (HIV), hepatitis B infection (including the presence of isolated anti-hepatitis B core), hepatitis C infection without prior curative treatment and sustained virologic cure, or evidence of immune suppression
•Diagnosis of 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
•Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV)
•Previously received OMS721

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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