Artemis-IGAN Clinical Trial

 
 

Omeros Corporation is sponsoring the ARTEMIS-IGAN clinical trial, a randomized, double-blind, placebo-controlled, Phase 3 study of the safety and efficacy of narsoplimab in patients with immunoglobulin A (IgA) nephropathy.

 

The purpose of this clinical trial is to see if the investigational drug narsoplimab is safe in people with IgA nephropathy and can help treat IgA nephropathy.

 

  • The primary outcome measure is the change in urine protein excretion at 36 weeks.
  • This clinical trial is being conducted in patients aged 18 years and older who have a diagnosis of IgA nephropathy and meet other eligibility criteria.
  • After screening and evaluation, those taking part will receive either narsoplimab or placebo for 12 weeks.
  • Those who do not respond will be considered for an additional six week of treatment.

 

Key Exclusion Criteria

  • Treatment with immunosuppressants (e.g. azathioprine, cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to screening
  • Clinical or biological evidence of systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgA nephropathy, or other renal disease
  • History of renal transplantation
  • History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or hepatitis C (HCV) infection  

 

Key Inclusion Criteria

  • Age 18 years or older
  • Biopsy-confirmed diagnosis of IgA nephropathy within the past 8 years
  • Protein of > 1 gram in 24-hour urine collection
  • Estimated glomerular filtration rate of ≥ 30mL/min/1.73 m2
  • Currently on physician-directed, stable treatment with renin-angiotensin system (RAS) blockade of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or direct renin inhibitors
  • Systolic blood pressure of < 150 mmHg and a diastolic blood pressure of < 100 mmHg at rest