2024-515058-26-00招募中3 期
Early rituximab treatment in children with idiopathic nephrotic syndrome Eng. ERICONS - Early RITUXIMAB in Childhood Onset Nephrotic Syndrome
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).
研究概览
简要总结
Assessment of the duration of disease remission in the study group compared to placebo
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Expresses the willingness to participate in the study and after obtaining information about the study, the patient / legal guardians will sign an informed consent form for participation in the study
- •Age at study entry> 2 years (> 24 months of age) and under 16 years of age
- •Meet the criteria for diagnosis of idiopathic steroid-dependent nephrotic syndrome (two relapses during steroid dose reduction or within two weeks of stopping steroid therapy) or nephrotic syndrome with frequent relapses (two or more relapses in 6 months on steroid therapy or four or more relapses in a period of 12 months)
- •Remission of NS immediately prior to study entry, defined as the absence or trace of protein in the urinalysis [uPCR <0.2 mg protein / mg creatinine (<20 mg protein / mmol creatinine) or <1+ in the test strip] for 3 consecutive days
- •Patients of childbearing age (conception) will commit to abstinence or to use effective contraception during the study period and up to 12 months after stopping RTX treatment; girls of childbearing potential will have a negative pregnancy test on qualifying for treatment initiation
排除标准
- •Previous use of immunosuppressants such as cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate mofetil, levamisole
- •Diagnosis of steroid-resistant NS, nephritic syndrome or secondary NS
- •Previous severe infection (tuberculosis, systemic mycosis), HIV, HCV, HBV infection
- •Active infection
- •Severe heart diseases (heart failure, myocardial infarction, severe heart rhythm disturbances)
- •Vaccinations with live vaccines within 4 weeks prior to study inclusion
- •Poorly controlled hypertension
- •Abnormal kidney function (eGFR <90 ml / min)
- •Autoimmune disease (IgA vasculitis, systemic lupus)
- •Current or history of cancer
- •Status after organ transplantation
- •Allergy to methylprednisolone, paracetamol, cetirizine, co-trimoxazole
- •Laboratory abnormalities: leukocyte count <3000 / µl, neutrocyte count <1500 / µl, platelet count <75,000 / µl, severe liver dysfunction: ALT or AST 2.5 times upper limit of normal
- •Prior treatment with monoclonal antibodies
- •Use of another study drug within the 6 months prior to study entry, or participation in other studies at screening
- •Severe immunodeficiency
- •Pregnancy, breastfeeding or refusal to use methods of contraception in case of the ability to become pregnant (pregnancy test required - beta hCG in the blood serum at enrollment in the study)
- •Hypersensitivity to the active substance, mouse proteins, or any of the excipients of the study drug (i.e. sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections)
结局指标
主要结局
Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).
Relapse-free survival (defined as the occurrence of proteinuria persisting for ≥ 3 days during the blinded phase (from day 1 to day 365)).
次要结局
- Time to treatment failure 1a. Percentage of failures in the experimental and placebo groups.
- Total dose of administered steroids.
- Time from depletion resolution to relapse.
- Relapse-free survival during the open-label phase (from the day of investigational drug administration to day 365 of observation).
研究者
Chief Medical Officer; Principal Investigator
Scientific
Medical University Of Gdansk
研究点 (9)
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