NCT03598036终止2 期
An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Proportion of Subjects With Remission of Proteinuria
研究概览
简要总结
Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
详细描述
The aim of the current study to assess the efficacy of voclosporin in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS). As well as to assess the safety and tolerability of voclosporin over 24 weeks in subjects with FSGS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary FSGS diagnosed by renal biopsy.
- •Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be immunosuppressant treatment-naïve, or receiving treatment with steroids.
- •Stable proteinuria, renal function, and BP.
排除标准
- •Clinical or histologic evidence of secondary FSGS.
- •Histologic evidence of collapsing variant FSGS.
- •eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment.
- •Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- •Current or medical history of:
- •Congenital or acquired immunodeficiency.
- •In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
- •Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
- •Current or past lymphoproliferative disease or previous total lymphoid irradiation.
- •Severe viral infection within 3 months of screening, or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
- •Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
研究组 & 干预措施
Voclosporin
Experimental
Cohort 1:
Maximum dose of 3 capsules (7.9mg) BID
Cohort 2
Dosing to be decided based on the safety from the first 5 or 6 subjects in Cohort 1.
干预措施: Voclosporin (Drug)
结局指标
主要结局
Proportion of Subjects With Remission of Proteinuria
时间窗: 24 weeks
Complete remission OR Partial remission
次要结局
- Proportion of Subjects With Complete Remission of Proteinuria(Weeks 8, 12, and 24)
- Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria(Weeks 8 and 12)
- Proportion of Subjects With Reduction of Proteinuria(Weeks 8, 12, and 24)
- Proportion of Subjects With Partial Remission of Proteinuria(Weeks 8, 12, and 24)
- Time to First Occurrence of Complete or Partial Remission of Proteinuria(Up to 26 weeks)
- Time to First Occurrence of Complete Remission of Proteinuria(Up to 26 weeks)
- Time to First Occurrence of Partial Remission of Proteinuria(Up to 26 weeks)
- Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline(Up to 26 weeks)
- Duration of Reduced Urine Protein Creatinine Ratio (UPCR)(Up to 26 weeks)
- Change From Baseline in Urine Protein Creatinine Ratio (UPCR)(Weeks 2,4,8,12,18,24)
- Proportion of Subjects With a Confirmed Decrease From Baseline in Estimated Glomerular Filtration Rate (eGFR)(Weeks 2,4,8,12,18,24)
- Proportion of Subjects With a Confirmed Increase in Estimated Glomerular Filtration Rate (eGFR)(Week 24 to Week 26)
- Change in Urine Protein Creatinine Ratio (UPCR)(Week 24 and Week 26)
- Change in Estimated Glomerular Filtration Rate (eGFR)(Week 24 and Week 26)
- Change From Baseline in Serum Creatinine, Serum Albumin and Estimate Glomerular Filtration Rate (eGFR)(Weeks 2,4,8,12,18,24)
- Quality of Life Assessments(Week 24)
- Safety and Tolerability (Treatment-Emergent Adverse Events)(24 weeks)
- Renal Biopsy(24 weeks)
研究者
研究点 (3)
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