EUCTR2014-001365-26-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration
Anthera pharmaceuticals, Inc0 个研究点目标入组 200 人开始时间: 2015年3月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •Subjects are eligible for enrollment if they meet the following inclusion criteria:
- •1.Male or female age 18 ? 65 years of age, inclusive.
- •2.Historical documentation of biopsy-proven IgA nephropathy according to definitions specified in the Oxford classification of IgA nephropathy (Appendix B). Histology should include evidence of staining of IgA in glomeruli by immunofluorescence of immunoperoxidase. Evidence of mesangial hypercellularity, segmental glomerulosclerosis, or endocapilllary hypercellularity must also be present.
- •3.Treatment with a stable clinically-optimized dose of ACEI and/or ARB for at least 90 days prior to screening.
- •4.Proteinuria > or = 1g/24hr but < or = 6g/24hr or equivalent as measured by random urine protein:creatinine ratio at 2 consecutive time points measured 2-6 weeks apart prior to randomization. At least one of these measures must be collected during screening.
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •1.Clinical or histologic evidence of lupus nephritis or membranoproliferative glomerulonephritis, or non-IgA-related glomerulonephritis.
- •2.Greater than 50% glomerulosclerosis or cortical scarring on renal biopsy or an Oxford Classification Score that includes T2.
- •3.Crescentic IgA nephropathy (> or =30%) or clinical evidence of rapidly progressive glomerulonephritis.
- •4.Henoch-Schonlein purpura resulting in nephropathy.
- •5.eGFR < or = 30 mL/min per 1.73 m2 in subjects with a qualifying biopsy within 1 year of screening, or eGFR < or = 40 mL/min per 1.73 m2 in subjects with a qualifying biopsy conducted more than 1 year before screening.
- •6.Blood uric acid > 1.5 times the upper limit of normal upon repeat testing at screening.
- •7.History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal upon repeat testing.
- •8.Poorly controlled hypertension (> or = 150/90 mmHg).
- •9.History of diabetes mellitus.
- •10.Known to be positive for human immunodeficiency virus (HIV) and/or positive at the screening visit for hepatitis B surface antigen, or hepatitis C virus.
- •11.History of Crohn?s disease or celiac sprue.
- •12.Anemia (hemoglobin <8 g/dL), neutropenia (< or = 1500 cells/?L), or thrombocytopenia (<75,000 cells/?L).
- •13.Malignancy within the past 5 years (other than a squamous or basal cell carcinoma of the skin which has been excised and considered cured). Those with history of malignancy greater than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer may be included in the study with documented evidence of conization or cure within the last 3 years.
- •14.Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days, or history of repeated herpetic viral infections (defined as more than 2 episodes in the year prior to screening). Other chronic infectious history should be discussed with the Medical Monitor.
- •15.History of active tuberculosis (TB). History of latent TB infection is also excluded unless there is documentation of appropriate anti TB therapy per Centers for Disease Control (CDC) guidelines or local regulations. In addition, the subject must not have any clinical signs/symptoms of active TB.
- •16.History of treatment with oral or parenteral corticosteroids for the treatment of IgA nephropathy within 3 months of screening or immunosuppressants within 6 months prior to screening. Treatment with oral or parenteral corticosteroids for non-IgAN related disease may be permitted at any time prior to or during the trial (please refer to protocol section 5.3 for specific requirements).
- •17.History of treatment with a molecule that targets the B-cell pathway within the last 12 months (e.g. rituximab, belimumab).
- •18.Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg), or live vaccines according to listed wash-out periods:
- •?Transfusion, IVIg, plasmapheresis or plasma exchange ? 90 days prior to screening
- •?Live vaccines ? 30 days prior to randomization
- •19.Females who are nursing, pregnant, intending to become pregnant or intending to nurse during the time of the study, or who have a positive pregnancy test at baseline. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control. Females and males are required to us
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