EUCTR2020-005835-60-FR进行中（未招募）1 期
Induction therapy for lupus nephritis with no added oral corticosteroids : An open label randomised multicentre controlled trial comparing oral corticosteroids plus mycophenolate mofetil (MMF) versus Obinutuzumab and MMF - OBILUP study
Assistance Publique – Hôpitaux de Paris (AP-HP)0 个研究点目标入组 196 人开始时间: 2021年5月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
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
- •-Children aged 14-17 years old and adults (until 75 years old)
- •-Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli
- •-Urine protein-to-creatinine ratio (uPCR) = 0.5 g/g at any time in the 14 days before inclusion
- •-Ability to provide informed and signed consent
- •-For child-bearing aged women, willingness to use appropriate and efficient contraception, as recommended when using MMF and obinutuzumab (18 months after inclusion)
- •-Affiliation to a French social security system (beneficiary or legal)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •-Severe critical SLE flare defined as any SLE manifestation requiring more immunosuppression than allowed within the protocol, in the physician's opinion
- •-Patients who cannot be prescribed 10 mg prednisone corticosteroids only, after inclusion according to their physician
- •-Prior use within 6 months preceding inclusion of therapeutic monoclonal antibody and/or B- or T cell modulating 'biologic' except belimumab that can be used up to 7 days before inclusion
- •-Contraindications to the use of IV methylprednisolone, MMF, oral corticosteroids or obinutuzumab, or its premedication drugs listed in the corresponding SmPCs
- •-Hypersensitivity to the active substances or to any of the excipients
- •-Obsolescence of >60% of the glomeruli or tubulointerstitial scarring of >60%
- •-CKD stage 4 or stage 5 defined as eGFR <30 ml/min/1.73 m2 according to CKD-EPI (to be differentiated from acute renal injury)
- •-Patients with gastro-intestinal ulcer with active bleeding
- •-Active infections, including but not limited to human immunodeficiency virus (HIV), hepatitis B in the absence of a specific therapy, hepatitis C or tuberculosis
- •-Receipt of a live-attenuated vaccine in the 4 weeks before study enrolment
- •-Patient who has presented a malignant pathology in the previous 2 years (with the exception of cervical cancer in situ)
- •-In female patients, known history of cervical dysplasia CIN Grade III, cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. However, the patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality was effectively treated >1 year ago).
- •-Patients with hepatic or pulmonary insufficiency
- •-Progressive cardiac pathology
- •-Patients with uncontrolled hypertension or hypotension
- •-Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •-Pregnancy and breast feeding
- •-Patient under tutorship or guardianship, and incapable to give informed consent
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