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

Omeros Corporation0 个研究点目标入组 450 人2018年4月20日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Omeros Corporation
入组人数: 450
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年4月20日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Omeros Corporation

入排标准

入选标准

•Age 18 years or older at the onset of Screening
•Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening or Run In Visit 1
•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

排除标准

•Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), Chinese Traditional Medicine with immunosuppressive function, 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. Males who are planning to father children 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.