A Randomized Controlled, Two-arm (1:1 Ratio) Phase IIa Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With de Novo Minimal Change Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks
研究概览
简要总结
OBELIX-NEPHROSIS (NS)
The goal of this clinical trial is to learn if obinutuzumab works to treat minimal change disease in adults. It will also learn about the safety of drug obinutuzumab. The main questions it aims to answer are:
Is obinutuzumab non-inferior to glucocorticoids at inducing remission? Does obinutuzumab provide superiority in terms of relapse-free survival after 52 weeks? What medical problems do participants have when receiving obinutuzumab? Researchers will compare drug obinutuzumab to glucocorticoids and aim to phenotype participants with minimal change disease.
Participants will:
Take the drug obinutuzumab (2 doses) or glucocorticoids Visit the clinic for 8 visits over a period of 52 weeks, plus additional controls when disease relapses occur
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
- •Male or female patients aged 18 years or older at the time of consent
- •Confirmed first episode of nephrotic syndrome at trial enrolment (serum albumin <30g/l and UPCR >3g/g creatinine (>300 mg/mmol) secondary to de novo MCD
- •Histologically confirmed MCD (latest before randomization to Arm A or B)
- •Only applies to women of childbearing potential (WOCBP):
- •Has a high sensitivity negative urine/serum pregnancy test at screening
- •Agrees to follow contraceptive guidance until 18 months after 2nd obinutuzumab treatment (if randomized to Arm B)
- •Only applies to trial sites in France: Patients affiliated with the French health care system
排除标准
- •MCD due to secondary causes, including malignancy of a type likely to be associated with MCD (i.e., lymphoproliferative disorders), or potentially related to treatment known to be associated with MCD occurrence (lithium, interferon, non-steroidal anti-inflammatory drugs)
- •Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive
- •Previous B cell depletion, independent of the agent and treatment target (i.e., CD20, CD38, etc.), within 18 months preceding baseline of the trial, or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets
- •Previous cyclophosphamide within 6 months preceding baseline of the trial
- •Treatment with Predniso(lo)ne within screening phase (before randomization)
- •Evidence of current or past infection with Hepatitis B, C or Human Immunodeficiency Virus (HIV) (unless appropriate prophylaxis is given and no replicating virus is detected)
- •Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug
- •Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)
- •Patient with a history of prior malignancy within 5 years before the first dose of study drug. Exceptions may apply for the following: malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer
- •Pregnant or breast-feeding women
- •Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks
- •Previous/known hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro
- •Co-enrolment in another clinical trial of an investigational medicinal product
- •Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
研究组 & 干预措施
Glucocorticoids
干预措施: Predniso(lo)ne (Drug)
Obinutuzumab
干预措施: Obinutuzumab Injection (Drug)
结局指标
主要结局
Non-inferiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients achieving remission (complete or partial) of MCD at 8 weeks
时间窗: From enrollment to the end of treatment at 8 weeks
Superiority of obinutuzumab to SoC predniso(lo)ne taper: Proportions of patients sustaining remission (complete or partial)/prevent relapses of MCD during the study period of 52 weeks
时间窗: From enrollment to the end of treatment at 52 weeks
次要结局
未报告次要终点