NCT03703908终止2 期
An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
研究概览
简要总结
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome
详细描述
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Male or female subjects aged 18 years and older
- •Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS
- •Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening
排除标准
- •Pregnant or nursing
- •History of organ transplantation, including renal transplantation
- •Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
- •Histological FSGS subtype of collapsing variant
- •Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient.
- •Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
- •Body Mass Index (BMI) ≥ 40
研究组 & 干预措施
Sequential
Experimental
All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.
干预措施: CCX140-B (Drug)
结局指标
主要结局
The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
时间窗: Baseline to week 12
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
次要结局
- Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment(Baseline to week 12)
- Proportion of Subjects With Achievement of Complete Remission During the Treatment Period(Baseline to week 52)
- Time Taken of Subjects to Achieve Complete Remission During the Treatment Period(Baseline to week 52)
- Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time(Baseline to week 12 and week 52)
- Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period(Baseline to week 52)
- Time to Rescue Therapy(Baseline to week 52)
- Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time(Baseline to Week 12 and Week 52)
- Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time(Baseline to Week 12 and Week 52)
- Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time(Baseline to Week 12 and Week 52)
- Mean Change From Baseline for the MDRD Creatinine Equation Over Time(Baseline to Week 12 and Week 52)
- Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2(Baseline to Week 52)
- Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial(Baseline to Week 12 and Week 52)
- Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial(Baseline to Day 57)
研究者
研究点 (5)
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