NCT03453619已完成2 期
A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 14
- 主要终点
- Part A: Change From Baseline in Proteinuria at Week 48
研究概览
简要总结
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
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
- •Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI)
- •Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation
- •IgAN: Prior biopsy results for C3 and C4d staining should be made available
- •LN: Diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (Class III, IV or V, respectively) by renal biopsy. Subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes)
- •Primary MN: PLA2R positive titer plus nephrotic range proteinuria (defined as uPCR >2350 mg/g)
- •C3G plus one of the following: Low serum C3 level or historical renal biopsy within the last 3 years
- •Have proteinuria >750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a).
- •eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis
- •Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics.
- •Willing to receive vaccinations against Neisseria meningitidis at least 2 weeks prior to dosing on Day 1 with a booster on Day 56 (for both vaccinations) and Pneumococcal and Hib vaccines at least 2 weeks prior to dosing on Day 1.
排除标准
- •Absolute neutrophil count <1000 cells/mm3 at screening Visits 3a and 3b
- •ALT or AST >3.0 x the upper limit of normal at screening Visits 3a and 3b
- •Previous treatment with APL-2
- •History of solid organ transplant
- •Diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening Visits 3a and 3b (previous HBV or HCV diagnosis cleared by treatment is allowed)
- •Renal disease secondary to another condition (e.g. infection, malignancy, monoclonal gammopathy, or a medication)
- •Presence or suspicion of active bacterial or viral infection or severe recurrent bacterial infections
- •Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period
- •Unwillingness to receive or intolerant of SC infusions of study medication or known allergy to ingredients in APL-2.
研究组 & 干预措施
APL-2
Experimental
Open Label, Study Drug, APL-2
干预措施: APL-2 (Drug)
结局指标
主要结局
Part A: Change From Baseline in Proteinuria at Week 48
时间窗: Baseline (Day 1) and Week 48
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Part B: Change From Baseline in Proteinuria at Week 168
时间窗: Baseline (Part A, Week 48) and Week 168
Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
次要结局
- Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B(Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168)
- Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B(Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168)
- Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B(Part A: Week 48; Part B: Week 168)
- Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B(Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168)
- Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B(Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168)
- Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B(Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168)
研究者
研究点 (14)
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