JPRN-jRCT1091220380已完成3 期
Multicenter double-blind, randomized, placebo-controlled trial of IDEC-C2B8 for the treatment of childhood-onset nephrotic syndrome(JSKDC10) - JSKDC10
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Diagnosed as idiopathic nephrotic syndrome (INS) according to the ISKDC criteria.
- •(2) First onset of INS is under 18 years of age.
- •(3) Subjects who are diagnosed as frequent recurrence or steroid dependency with recurrence just before registration and who can confirm the date of recurrence as the basis for diagnosis.
- •(4) Subjects who have not been treated with immunosuppressive treatment for INS.
- •(5) Diagnosed as steroid-sensitive relapse.
- •(6) CD20 positive B-cells >/= 5/mcL in the peripheral blood.
- •(7) Subjects can be hospitalized for treatments.
- •(8) Subjects have ability to provide written informed consent form. The written informed consent form of legal representative is also required for subjects less than 20 years of age.
排除标准
- •(1) Subjects who have been diagnosed with steroid resistance NS.
- •(2) History of inflammatory nephritis such as IgA nephritis.
- •(3) Subjects falling under any of the following infectious diseases.
- •1) Subjects who have had a history of severe infection (pneumonia, pyelonephritis, etc.) requiring hospitalization within the past 6 months before registration.
- •2) Subjects who have had a history of opportunistic infection (cytomegalovirus infection, systemic fungal infection, pneumocystis infection, nontuberculous mycobacterial infection etc.) within 6 months before registration.
- •3) Subjects with active tuberculosis.
- •4) Subjects with or having suspected tuberculosis infection.
- •5) Subjects complicated with active hepatitis B or active hepatitis C, or patients confirmed to be hepatitis B virus carriers.
- •6) Subjects with confirmed HIV infection.
- •(4) Presence or history of angina pectoris, cardiac failure, myocardial infarction and/or serious arrhythmia grade 4 in Common Terminology Criteria for Adverse Events (ver. 4.0).
- •(5) Having received a live vaccine within 4 weeks prior to screening.
- •(6) Known hypertension which is uncontrollable with conventional anti-hypertensive.
- •(7) Deteriorated kidney function, e.g. estimated GFR<60mL/min./1.73m2.
- •(8) Presence or history of auto-immune diseases such as Hashimoto disease (Chronic thyroiditis), Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma or vascular purpura.
- •(9) Presence or history of cancer.
- •(10) History of organ transplantation.
- •(11) History of allergic reaction to acetaminophen and/or d-chlorpheniramine maleate.
- •(12) Subject falling under any of the following clinical laboratory findings.
- •1) WBC < 3,000/mcL
- •2) Neutrophil < 1,500/mcL
- •3) PLT < 50,000/mcL
- •4) AST(GOT) > 2.5 x ULN
- •5) ALT(GPT) > 2.5 x ULN
- •6) Positive for HBs antigen, HBs antibody, HBc antibody and HCV antibody
- •7) Positive for HIV antibody
- •(13) History of receiving any kinds of monoclonal antibody therapy.
- •(14) Having received any investigational agent within 6 months prior to enrollment, or participating other clinical studies.
- •(15) Subjects who do not agree with contraception during the study period (Negative HCG result is required at screening for female subjects after the first menstruation.).
- •(16) A female patient who is pregnant, has a possibility of pregnancy, or is breastfeeding.
- •(17) Judged inappropriate for this study by the physicians.
研究者
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