2024-514240-93-00招募中3 期
OBIRINS - Efficacy and Safety of Obinutuzumab versus Rituximab in childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : à double-blind multicenter randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 11
- 主要终点
- The primary outcome is the occurrence of a relapse defined as a 3+ proteinuria on dipstick on 3 consecutive days, with 1 laboratory urine dosage of Protein-over-creatinine ratio > 0.20g/mmol (> 0.2g/g), within 12 months following the initiation of Treatment.
研究概览
简要总结
To assess the superiority of one infusion of obinutuzumab compared to one infusion of rituximab on the relapse-free survival at 12-months.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 3 and < 18 ans
- •Steroid dependant Nephrotic Syndrome defined as: • 2 or more relapses during steroids or within 2 weeks following discontinuation. • OR 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal . OR Frequent Relapsing Nephrotic Syndrome defined as: • 2 or more relapses within 6 months following first remission or 3 or more relapses within any 12-month period
- •Last relapse within 3 months prior to inclusion
- •In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
- •Vaccination schedule in accordance with the current recommendations in France
- •Informed consent from parents
排除标准
- •Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
- •History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
- •Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
- •Known hyperprolinemia
- •Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
- •Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
- •Patient without medical insurance coverage (beneficiary or legal)
- •Primary or secondary steroid resistance nephrotic syndrome
- •Prior treatment with Rituximab within 6 months
- •Prior treatment with obinutuzumab at any time
- •CD20+ B-cell count < 2.5%
- •Patient with neutrophils < 1.5 G/L and/or platelets < 75 G/L
- •GFR < 80 ml/min/1.73m2
- •Weight <16kg
- •History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
结局指标
主要结局
The primary outcome is the occurrence of a relapse defined as a 3+ proteinuria on dipstick on 3 consecutive days, with 1 laboratory urine dosage of Protein-over-creatinine ratio > 0.20g/mmol (> 0.2g/g), within 12 months following the initiation of Treatment.
The primary outcome is the occurrence of a relapse defined as a 3+ proteinuria on dipstick on 3 consecutive days, with 1 laboratory urine dosage of Protein-over-creatinine ratio > 0.20g/mmol (> 0.2g/g), within 12 months following the initiation of Treatment.
次要结局
- To assess the superiority of obinutuzumab compared to rituximab on the relapse-free survival at 24-months
- To compare the duration of B-cell depletion after OBI and RTX
- To compare the relapse-free survival after B-cell recovery after OBI and RTX
- To compare the number of relapses, steroid courses and second line treatment strategies required within 24 months in both arms
- To compare the safety of the two treatments including infusion-related reactions, infections, levels of immunoglobulins, neutropenia
- To assess the factors associated with sustained remission
- To assess the cost-effectiveness of the OBI strategy
- To assess the budgetary impact of the generalization of the OBI strategy
- To assess pharmacokinetics of Obinutuzumab and Rituximab
- To assess the development of antidrug antibodies
研究者
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (11)
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