IgA nephropathy (IgAN)
Conditions
Interventions
Product Code: OMS721
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OMS721
Current Sponsor code: OMS721
Other descriptive name: OMS721
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Omeros Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 18 years or older at the onset of Screening •Biopsy confirmed diagnosis of IgAN within 10 years prior to Screening •Proteinuria of > 1 g in 24-hour urine collection at Screening and baseline •Estimated glomerular filtration rate of = 30 and = 90 mL/min/1.73 m2 at Screening and baseline •Currently on physician-directed, stable treatment with RAS blockade (ACEIs, ARBs, direct renin inhibitors) and have a systolic BP of =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: •Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to Screening •Unwilling or unable to discontinue systemic corticosteroids 12 weeks prior to Randomization •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 diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch Schonlein purpura), secondary IgAN, or other renal disease •Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening •History of renal transplantation •Have a known hypersensitivity to any constituent of the investigational product •Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m2 within 24 weeks or > 15 mL/min/1.73 m2 within 3 months prior to Screening •Significant abnormalities in clinical laboratory values •Body mass index = 35 kg/m² •History of human immunodeficiency virus (HIV), hepatitis B infection (including the presence of isolated anti-hepatitis B core), hepatitis C infection without prior curative treatment and sustained virologic cure, or evidence of immune suppression •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) •Previously received OMS721
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the effect of OMS721 in patients with IgA nephropathy (IgAN) on proteinuria assessed by 24-hour urine protein excretion (UPE) in g/day at 24 weeks from beginning of treatment (BOT);Secondary Objective: To evaluate the effect of OMS721 in patients with IgAN on: •Safety and tolerability assessed by adverse events (AEs), vital signs, laboratory tests, and ECGs •Renal function as determined by the rate of change in eGFR up to 144 weeks from BOT •Proteinuria assessed by UPE at 24 weeks from BOT in the subset of patients with baseline high proteinuria (24-hour UPE = 2 g/day) •Per-protocol-defined responder at 24 weeks •Per-protocol-defined partial-responder at 24 weeks •Time-averaged change in urine protein/creatinine ratio •Proportion of patients who achieve partial proteinuria remission (24-hour UPE < 0.6 g/day) •Proportion of patients who achieve complete proteinuria remission (24-hour UPE < 0.3 g/day) •Proportion of patients who received rescue therapy for IgAN at any time during the study •Pharmacokinetics, pharmacodynamics, and immunogenicity of OMS721;Primary end point(s): •The primary endpoint of this study is the change from baseline in 24-hour UPE at 24 weeks from BOT.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Safety and tolerability of OMS721 for the treatment of IgAN as assessed by AEs, vital signs, clinical laboratory tests, and ECGs •The rate of change in eGFR up to 144 weeks from BOT •Change from baseline in 24-hour UPE at 24 weeks from BOT in patients with baseline 24 hour UPE = 2 g •Achievement of a treatment response defined as = 30% reduction from baseline in 24 hour UPE at 24 weeks •Achievement of a partial response defined as a reduction between = 15% and < 30% from baseline in 24-hour UPE at 24 weeks •Time averaged change from baseline in uPCR through 24 weeks. This will be measured as the time adjusted area-under-the-curve •Achievement of partial proteinuria remission defined as 24-hour UPE < 0.6 g/day at any time during study •Achievement of complete proteinuria remission defined as 24-hour UPE < 0.3 g/day at any time during study •Use of rescue therapy for IgAN at any time during the study •Change from baseline in eGFR at 24 weeks from BOT •Pharmacokinetics and pharmacodynamics of OMS721 •Occurrence of ADA and, if present, NAb;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactAnita Burroughs
INC Research LLC
Outcome results
None listed