ARTEMIS‐IgAN 2018.

Trial name or title	Study of the safety and efficacy of OMS721 in patients with immunoglobulin A (IgA) nephropathy
Methods	Parallel RCT
Participants	Setting: not yet available Country: USA Patients aged 18 years and above with a biopsy‐confirmed diagnosis of IgAN within 10 years, with 24‐hour urinary protein excretion that is > 1 g/day at baseline, eGFR of ≥ 30 and ≤9 0 mL/min/1.73 m2, currently on physician‐directed, stable treatment with RAS blockade (ACEI, ARB, direct renin inhibitors) and have a systolic BP of <150 mmHg and a diastolic BP of <100 mmHg at rest Number: approximately 430 patients are to enrolled in two groups of 215 patients per arm Mean age ± SD (years): not yet available Sex (M/F): not yet available Exclusion criteria: Treatment with immunosuppressants (e.g., AZA or CPA), cytotoxic drugs, or eculizumab within 24 weeks prior to screening; unwilling or unable to discontinue systemic corticosteroids 12 weeks prior to randomisation; 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 re treatments; clinical or biological evidence of DM, systemic lupus erythematosus, IgA vasculitis (HSP), secondary IgAN, or other renal disease; history of renal transplantation; have a known hypersensitivity to any constituent of the investigational product; rapidly progressive GN; significant abnormalities in clinical laboratory values; BMI ≥ 35 kg/m2, history of HIV (HIV), hepatitis B infection and hepatitis C infection; 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
Interventions	Treatment group 1 OMS721 Treatment group 2 Placebo (5% dextrose in water or normal saline solution)
Outcomes	Change from baseline in 24‐hour urine protein excretion in g/day at 24 weeks from beginning of treatment Number of patients with treatment related adverse events as assessed by CTCAE v 4.0 Change from baseline in kidney function as determined by the rate of change in eGFR up to 144 weeks from beginning of treatment Change from baseline in 24‐hour urine protein excretion in g/day at 24 weeks from beginning of treatment in the subset of patients with baseline high proteinuria (defined as 24‐hour urinary protein excretion ≥ 2 g/day) Time‐averaged change in UPCR through 24 weeks
Starting date	February 2018
Contact information	Laura Haas (206) 676‐0886 lhaas@omeros.com Fay Wang (206) 676‐0863 fwang@omeros.com
Notes	Estimated study completion date: April 2023 No study results available