Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Chronic Kidney Disease
Enrollment Eligibility
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)