NCT04983888已完成2 期
A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in proteinuria
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥ 18 years of age.
- •Biopsy proven Focal Segmental Glomerulosclerosis (FSGS) lesion
- •Foot process effacement ≥ 80% on electron microscopy.
- •Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy.
- •Resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. Patient who have contraindication to or refuse to take high dose corticosteroids are allowed.
排除标准
- •Genetic or secondary forms of FSGS.
- •Hepatitis B, C or HIV positive.
- •Pregnant or breast-feeding.
- •Active infection.
- •Kidney transplant.
- •Anemia with Hgb < 8.0 g/dL.
- •Thrombocytopenia with platelet count < 100'
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
- •Patients who have received cyclophosphamide in the last 6 months.
- •Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment.
- •For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug.
- •For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug.
研究组 & 干预措施
Primary Focal Segmental Glomerulosclerosis (FSGS)
Experimental
Subjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Change in proteinuria
时间窗: Baseline, 6 months, 12 months
Measured using 24 hour urine collection reported in mg/24h
次要结局
- Remission status at 12 months(12 months)
- Change in serum albumin(Baseline, 6 months, 12 months)
- Serious Adverse Events (SAEs)(24 months)
- Proteinuria at 18 months(18 months)
- Proteinuria at 24 months(24 months)
- Remission status at 6 months(6 months)
研究者
Fernando Fervenza
Principal Investigator
Mayo Clinic
研究点 (2)
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