KCT0002470招募中未知
A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.
Corestem0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 69(Year)（—）
- 性别
- All
入选标准
- •1) Male and female Patients aged =18 years and = 70years.
- •2) Patients with HLA-haplo-matched bone marrow donor is less than 70 years old.
- •3) Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- •4) Patients had suffered from active renal disease in the past or patients has active renal disease now. Active renal disese should have include below.
- •(1) Spot urine protein/creatinine ratio = 1.0 and ? >5 RBC/HPF, ? >5 WBC/HPF, ? columnar cell.
- •(2) Biopsy confirmed active type III or type IV, or type V lupus nephritis.
- •5) Patients can be immunosuppressive agent to , steroids, taking, such as anti-Malarials (hydroxychloroquine) in a certain capacity, during the test period, to maintain the same capacity before 4-weeks screening.
- •6) Patients who consented to participate in the study in writing by themselves or their legal representatives
排除标准
- •1) Those who do not kidney disease for SLE.
- •2) Patients with a history of hypersensitivity, such as heavy metal poisoning similar to drug testing and drug ingredients.
- •3) Patients a history Major organs (kidney, liver, lung, heart) transplant or liver hematopoietic cells / transplant or during of scheduled transplantation clinical trial.
- •4) Patients a history of kidney dialysis or during of the scheduled dialysis clinical trials within 2 weeks prior to the screening.
- •5) Tested positive for hepatitis B(HBsAg, Anti-HBcAB, HBV-DNA) and hepatitis C(Anti-HCV, HCV-RNA) \.
- •6) Patients a history of anaphylactic reaction for the parenteral administration of a monoclonal antibody or contrast agent, a mouse protein or human.
- •7) Patients whose e-GFR = 30mL/min at screening.
- •8) Patients with a history of malignancy within 5 years prior to the screening(basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical intraepithelial neoplasia are excluded).
- •9) Patients who were administered drug of the follow within 6 months prior to the screening.
- •- nitrogen mustard, chlorambucil, vin·cris·tine, procarbazine, Abatacept, Rituximab, Belimumab
- •10) Patients who were administered drug of the follow within 3 months prior to the screening.
- •- Anti-TNF(tumor necrosis factor) therapy(Etanercept, adalimumab, Infliximab, golimumab, Tocilizumab)
- •- Interleukin-1 receptor antagonist(anakinra)
- •- Intravenous immunoglobulin(IVIG)
- •- Plasmapheresis
- •11) Those who are hypersensitive to antibiotics including penicillin and streptomycin.
- •12) Patients with systemic infection at screening.
- •13) Uncontrolled hypertension or diabetes.
- •14) If that may affect proteinuria increased capacity or begin taking medication(ACE(Angiotensin converting enzyme) inhibitors, ARB (Angiotensin Receptor Blocker)) (However, more than four weeks allowed capacity, taking is possible during the trial period without changing capacity).
- •15) Patients who showed myocardial infarction or angina on ECG at screening, or received stent procedure or bypass.
- •16) Patients who were administered another study drug 3 months prior to the study.
- •17) Patients with severe mental disease(for example, schizophrenia, bipolar disorder etc;).
- •18) Patients are expected to be administered the combination contraindicated drugs about inevitable or taker within clinical trial.
- •19) Women of childbearing age are not implement adequate contraception during clinical trials. the proper method of contraception, which has Oral contraceptive continued more than four weeks, a surgical procedures including the insertion loop, condom use etc. and Medically it is determined that there is no possibility of pregnant women do not belong to women of childbearing age due to the ovary removal, hysterectomy and menopause, etc.
- •20) Pregnant women or nursing women.
- •21) Except as permitted in the following Case and laboratory test results than moderate adverse events(NCI-CTC (National Cancer Institute-Common Toxicity Criteria) version 4.0) grade 3.
- •- proteinuria
- •- hematuria
- •- Columnar
- •- Hypoalbuminemia caused by lupus nephritis
- •- Class III due to stable prothrombin time of warfarin therapy
- •- Lupus anticoagulant group, and are not associated with liver disease or stable anticoagulation 3 grade partial thromboplastin time
- •- Lupus due to hepatitis and alcoholic liver disease, are not associated with uncontrolled diabetes or viral hepatitis stable 3 grade gamma glutamyl transferase (GGT) increases. If it appears to be le
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