A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients With Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- change from baseline in urine protein-creatinine ratio (UPCR)
研究概览
简要总结
This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.
详细描述
This is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of SGB-9768 in patients with primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. The primary objective is to evaluate efficacy of SGB-9768 in reducing urine protein excretion and maintain kidney function in these patients. Secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Aged ≥18 years
- •Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg/m²
- •Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.
- •Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g
- •Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL/min/1.73 m².
- •Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks
- •Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug
排除标准
- •Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.
- •Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.
- •IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases
- •Presence of other systemic diseases or kidney diseases that may cause proteinuria
- •Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug
- •Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug
- •Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more
- •Significant comorbidities
- •History of any malignant tumors of any organ system within the past 5 years
- •History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.
- •History of immunodeficiency diseases, congenital asplenia or splenectomy.
- •History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections
- •Positive test results for HBV, HCV, HIV
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2.5 times the upper limit of normal (ULN)
研究组 & 干预措施
C3G/IC-MPGN
2 doses of SGB-9768 by subcutaneous (sc) injection
干预措施: SGB-9768 (Drug)
IgAN-1
2 doses of SGB-9768 by subcutaneous (sc) injection
干预措施: SGB-9768 (Drug)
IgAN-2
2 doses of SGB-9768 by subcutaneous (sc) injection
干预措施: SGB-9768 (Drug)
结局指标
主要结局
change from baseline in urine protein-creatinine ratio (UPCR)
时间窗: 24 weeks
次要结局
- change from baseline in UACR and 24h-urine protein(24 weeks)
- change from baseline in estimated glomerular filtration rate (eGFR)(36 weeks)
- Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)(from erollment through week 36)
- Pharmacokinetics-Cmax(24 hours)
- Pharmacokinetics-Tmax(24 hours)
- Pharmacokinetics-AUClast(24 hours)
- Pharmacokinetics-t1/2(24 hours)
- Pharmacodynamics-C3(baseline through week 36)
- Pharmacodynamics-complement classical pathway activity by Wieslab® CP(baseline through week 36)
- Pharmacodynamics-complement alternative pathway activity by Wieslab® AP(baseline through week 36)