EUCTR2018-000075-33-ES进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 434
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 150 mmHg and a diastolic BP of < 100 mmHg at rest
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •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
研究者
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