EUCTR2018-000075-33-GB
Active, not recruiting
Phase 1
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) - ARTEMIS-IGA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Omeros Corporation
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older at the onset of Screening
- •Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
- •Documented history of 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 410
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 8 weeks prior to Screening, unless such treatment is given for indications other than IgAN
- •Treatment with systemic corticosteroids within 8 weeks prior to Screening
- •Uncontrolled BP, a systolic BP of \> 150 mmHg and a diastolic BP of \>100 mmHg at rest despite the combination of two or more antihypertensives including ACE inhibiters, ARBs, or direct renin inhibitors
- •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 or Run\-In
- •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 12 weeks prior to Screening. During the Run\-In period a patient will be excluded if they experience a decrease in eGFR of \> 15 mL/min/1\.73 m2 from their best eGFR from the beginning of Screening.
Outcomes
Primary Outcomes
Not specified
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