Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    450
  • sponsor
    Omeros Corporation
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Updated on 5 March 2022
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glomerular filtration rate
nephropathy
immunoglobulins
proteinuria
immunoglobulin a

Summary

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.

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.

Details
Condition IgA Nephropathy
Treatment OMS721, Vehicle (D5W or saline)
Clinical Study IdentifierNCT03608033
SponsorOmeros Corporation
Last Modified on5 March 2022

Eligibility

 Yes No Not Sure

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
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)
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