A Study to Evaluate the Safety and Effectiveness of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy


About this study

The purpose of this study is to evaluate the safety and effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 m^2 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 immuno-suppressants 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.
  • Significant abnormalities in clinical laboratory values.
  • History of human immunodeficiency virus (HIV), evidence of immune suppression, active HCV infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nelson Leung, M.D.

Open for enrollment

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Leslie Thomas, M.D.

Open for enrollment

Contact information:

Myranda Semlacher R.N.

(480) 301-4260


More information


Publications are currently not available

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