OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

• Age 18 years or older at the onset of Screening
• Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
• Documented history of proteinuria of > 1 g/day within 6 months prior
to Screening, or uPCR > 0.75 by spot urine at Screening
• Mean of two proteinuria measurements > 1 g/day at baseline
• Estimated glomerular filtration rate of = 30 mL/min/1.73 m2 at
Screening and baseline
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 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Treatment with immunosuppressants (e.g., azathioprine or
cyclophosphamide), cytotoxic drugs, or eculizumab within 8 weeks prior
to Screening, unless such treatment is given for indications other than
IgAN
• Treatment with systemic corticosteroids within 8 weeks prior to Screening
• Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of
>100 mmHg at rest despite the combination of two or more
antihypertensives including ACE inhibiters, ARBs, or direct renin
inhibitors
• 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 Type 1 diabetes mellitus (DM) or
poorly controlled DM with hemoglobin A1c > 7.5, or with evidence of
diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA
Vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal
disease, during Screening or Run-In
• 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
12 weeks prior to Screening. During the Run-In period a patient will be
excluded if they experience a decrease in eGFR of > 15 mL/min/1.73 m2
from their best eGFR from the beginning of Screening.
• Significant abnormalities in clinical laboratory values including any of
the following at the time of evaluation during Screening and Run-In:
a. hemoglobin < 9.0 g/dL
b. platelet count < 100,000 cells/mm3
c. absolute neutrophil count < 500 cells/mm3
d. alanine transaminase or aspartate transaminase (AST) > 3.0 × the
upper limit of normal (ULN)
e. serum bilirubin > 2 × ULN
• History of human immunodeficiency virus (HIV), evidence of immune
suppression, active hepatitis C virus (HCV) infection (patients with
positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll),
hepatitis B virus (HBV) infection (patients with positive HBsAg are
excluded. For patients with isolated positive anti-HBc antibody, HBV DNA
test by PCR must be non-detectable to enroll).
• 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) or within 5 times

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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Updated 10/3/2023