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Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
Overall Recruitment Status: Enrollment not started
 
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)
 
Region Sponsors
California - Northern
Omeros Corporation
 
Acronym KP IRB No.
1710873
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Male and Female with IgA Nephropathy
 
Purpose
The purpose of this study is to evaluate the safety and efficacy of OMS721 in patients with IgA nephropathy. The study will assess proteinuria by 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment
 
Detailed Description
This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening. During the study, all patients will continue optimized renin-angiotensin system (RAS) blockade. The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-36), and Follow-Up (Weeks 37-144). Patients are assessed for re-treatment based on their response to 24-hour UPE. Additional treatment may be given to patients whose 24-hour UPE is > 1 g/day following the Initial Treatment Period and who relapse during the Response Evaluation and Follow-Up periods. Patients may be qualified for Open-Label Treatment with OMS721 after Week 72. Approximately 450 patients are to enrolled in two groups of 225 patients per arm.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Age 18 years or older at the onset of Screening
  • Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
  • 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
 
Exclusion Criteria
  • Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgA within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN
  • Treatment with eculizumab within 8 weeks prior to Screening
  • Treatment with eculizumab is not allowed during the Run-In Period
  • Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period
  • Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of > 100 mmHg at rest despite the combination of two or more anti-hypertensives including ACEIs, ARBs, or direct renin inhibitors at Screening and baseline
  • 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 and Run-In
  • History of renal transplantation
  • Have a known hypersensitivity to any constituent of the investigational product
  • Rapidly progressive glomerulonephritis
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Autoimmune Diseases
  • Nephritis
  • Glomerulonephritis
  • OMS721-IGA-001
  • Glomerulonephritis, IGA
  • Urologic Diseases
  • Immune System Diseases
  • Nephrology
  • Kidney Diseases
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Nephrology


Principal Investigator:
Ali X Poyan Mehr, MD
Contact Information:
- Monica X Kim, RN
-Monica.X.Kim@kp.org
-San Francisco Medical Center


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