2023-505140-19-00招募中3 期
A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 14
- 主要终点
- 1. Percentage of Participants with Sustained Complete Remission at 1 year
研究概览
简要总结
- To evaluate the efficacy of obinutuzumab compared with MMF
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety Follow-Up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS) before the age of 18 years
- •Must be in complete remission defined by the absence of edema, UPCR ≤ 0.2 g/g at screening and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
- •Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
- •Participants having received cyclophosphamide in the 6 months prior to randomization must have experienced at least 1 relapse subsequent to cyclophosphamide discontinuation
- •Estimated glomerular filtration rate (eGFR) within normal range for age
排除标准
- •Secondary nephrotic syndrome
- •History of steroid resistant nephrotic syndrome. History of genetic defects known to directly cause nephrotic syndrome
- •Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
- •Pregnancy or breastfeeding or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab, or within 6 weeks after the final dose of MMF
- •Females of childbearing potential, including those who have had a tubal ligation, must have a negative serum pregnancy test result within 28 days prior to initiation of study treatment and a negative urine pregnancy test at Day 1, prior to randomization
- •Patients demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
结局指标
主要结局
1. Percentage of Participants with Sustained Complete Remission at 1 year
1. Percentage of Participants with Sustained Complete Remission at 1 year
次要结局
- 1. Overall relapse-free survival (RFS)
- 2. Probability of RFS at Week 52
- 3. Cumulative corticosteroid dose
- 6. Proportion of patients with sustained complete remission at Week 76
- 4. Number of relapses
- 5. Proportion of participants experiencing edema associated relapse during the 52-week treatment period
- 7. Mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue scale total score from baseline to Week 52
- 8. Mean change in “Physical Functioning” domain of PedsQL-Quality of Life Inventory from baseline to Week 52
- 9. Mean change in CureGN Edema Scale from baseline to Week 52
- 10. Incidence, nature, and severity of adverse events, with severity determined according to AE intensity (mild, moderate, severe, life-threatening) and NCI CTCAE grading if applicable from baseline to Week 52
- 11. Incidence of laboratory or vital sign abnormalities from baseline to Week 52
- 12. Serum concentrations of obinutuzumab at specified timepoints
- 13. Proportion of participants achieving B-cell depletion (HSFC) at specified timepoints
- 14. Total peripheral B cell and B cell subsets (e.g., memory B cells) counts and change from baseline at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (14)
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