TCTR20190517004进行中（未招募）4 期
rine Interferon Inducible Protein-10 Guided Treatment to Reduce Lupus Nephritis Flares: A Prospective Randomized-controlled Trial
ational Science and Technology Development Agency0 个研究点目标入组 216 人开始时间: 2019年5月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
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
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1.Age 18-65 years
- •2.Diagnosis of SLE according to American College of Rheumatology (ACR) 1997 or The Systemic Lupus International Collaborating Clinics (SLICC) criteria
- •3.History of lupus nephritis, either clinical diagnosis or biopsy proven lupus nephritis class III, IV or V who completed at least 3-month course of induction therapy
- •4.Achieved remission within 12 months from the initiation of induction therapy, defined by more than 50% reduction of proteinuria from baseline and the level less than 3 g/g or g/day
- •5.Urinary protein level < 3 g/g or g/day in the past 6 months
- •6.Immunosuppressive medications were not increased for at least 3 months.
排除标准
- •1.Clinical renal flare in the past 6 months defined by:
- •1.1Equal or more than 25% increase of creatinine for at least 2 consecutive times in the past 6 months without other contributing factors and/or
- •1.2If baseline uPCR is:
- •1.2.1 Equal or less than 500 mg/g, an increase to more than 1000 mg/g for at least 2 consecutive times in the past 6 months without other contributing factors
- •1.2.2 More than 500 mg/g, an increase of equal or more than 2-fold for at least 2 consecutive times in the past 6 months without other contributing factors
- •2.Severe extra-renal involvement of SLE
- •3.Receipt of prednisolone more than 7.5 mg/day
- •4.Receipt of mycophenolate mofetil(MMF) more than 1.5 g/day
- •5.Receipt of azathioprine more than 2 mg/kg/day
- •6.Receipt of methotrexate more than15 mg/week
- •7.Receipt of calcineurin-inhibitor
- •8.Receipt of leflunomide
- •9.Treatment with cyclophosphamide within the past 6 months
- •10.Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time within 12 months
- •11.Estimated-GFR less than 30 mL/min/1.73 m2
- •12.Pregnancy or breast feeding
- •13.Poor compliance
- •14.Known active, clinically significant infection of any kind
- •15.History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
- •16.Poorly controlled diabetes mellitus (HbA1c > 8% in the past 6 months)
- •17.Uncontrolled concomitant disease
- •18.Contraindications for treatment with corticosteroids, such as a history of steroid induced psychosis.
研究者
相似试验
已完成
不适用
Interferon (IFN) induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4Hepatitis C virus (HCV)Infections and InfestationsChronic viral hepatitisISRCTN59358441Academic Medical Centre (AMC) (Netherlands)58
已完成
不适用
Interferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4.chronic hepatitis CNL-OMON27278AMC Liver Center, Department GastroAcademic Medical Center, University of Amsterdam58
已完成
不适用
tility of the enzyme-linked immunospot interferon-gamma-release assay to predict the risk of infection in kidney transplant recipientsInfection in kidney transplant recipientsCMVBK virusinterferonelispotimmunityimmunocompromisedTCTR20210216004Ramathibodi Hospital100
进行中（未招募）
不适用
COMBINED THERAPY WITH PEG-INTERFERON-a, RIBAVIRIN AND RITUXIMAB OF HEPATITIS C VIRUS-RELATED MIXED CRYOGLOBULINEMIA - NDpatients anti-HCV, HCV RNA positivity, Na?ve, with cryoglobulinemic vasculitis (detection of serum cryoglobulins associated with purpura, arthralgias and weakness)and with chronic hepatitisMedDRA version: 9.1Level: SOCClassification code 10005329EUCTR2010-020659-30-ITAZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
招募中
不适用
Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trialchronic hepatitis BJPRN-UMIN000011666Toranomon Hospital100