EUCTR2018-000075-33-GB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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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 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
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •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.
- •Significant abnormalities in clinical laboratory values including any of the following at the time of evaluation during Screening and Run-In:
- •a. hemoglobin < 9.0 g/dL
- •b. platelet count < 100,000 cells/mm3
- •c. absolute neutrophil count < 500 cells/mm3
- •d. alanine transaminase or aspartate transaminase (AST) > 3.0 × the upper limit of normal (ULN)
- •e. serum bilirubin > 2 × ULN
- •History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), hepatitis B virus (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) or within 5 times the plasma half-life of the administered experimental drug, whichever is longer
- •Presence of active infection occurring within 7 days of Screening or at the time of Screening
研究者
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