An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This is an open-label Phase 2a clinical study designed to evaluate the safety and efficacy of AVB-S6-500 in patients with IgA Nephropathy (IgAN). Approximately 24 patients will be enrolled. Several dose levels of AVB-S6-500 may be evaluated.
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
- •Diagnosis of biopsy-proven IgAN
- •Proteinuria ≥ 1g to 3g/24hr
- •Stable estimated glomerular filtration rate (eGFR) for at least 3 months prior to screening and ≥ 45 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula
- •Systolic BP lesser than or equal to 150 mmHg and diastolic BP lesser than or equal to 100 mmHg
- •Patients who have been on a steady dose of ACE or ARB inhibitors for at least 3 months and throughout screening and who are not expected to have their dose adjusted during the study are allowed on study (patients who are not on ACEi/ARB due to inability to tolerate these therapies are also allowed)
- •If a sexually-active patient, must agree to use a reliable method of birth control from at least 4 weeks prior to first dose of study drug, during the study and for 1 month following completion of therapy.
排除标准
- •Patients with chronic urinary tract infections (UTIs) or taking prophylactic antibiotics to prevent recurrent UTIs
- •Treatment with systemic immunosuppressants, including corticosteroids, within 8 weeks of the first dose of study drug
- •Rapidly progressing nephropathy defined as falling GFR (≥ 15%) over past 3 mos
- •Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease
- •Hemoglobin < 9.0 g/dL
- •History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal
- •Organ transplant recipient (including bone marrow) or a planned transplant during the study
- •Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening
- •Recent active infection requiring hospitalization or i.v. treatment within 30 days prior to the first dose of study drug
- •Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg) within 90 days prior to screening
- •Malignancy within the past 5 years. Exceptions are squamous cell carcinoma of skin, basal cell carcinoma of skin, and cervical carcinoma in situ which have been excised and are considered cured
- •Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline
- •Exposure to an investigational drug or device within 90 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
- •Known sensitivity to any of the products to be administered during dosing
- •Subject will not be available for follow-up assessment
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- •Prior exposure to AVB-S6-500
研究组 & 干预措施
Treatment with AVB-S6-500
Patients will receive AVB-S6-500 by intravenous infusion every 2 weeks for total of 6 doses.
干预措施: AVB-S6-500 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: 14 weeks
Measured by the number of patients with AEs
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.
时间窗: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day in the Subset of Patients With Baseline High Proteinuria.
时间窗: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment
时间窗: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients Who Had at Least a Decrease of 0.5 g/Day Proteinuria From Baseline to End of Treatment.
时间窗: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).
时间窗: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).
时间窗: 12 weeks
次要结局
- Titers of Anti-AVB-S6-500 Antibodies(14 weeks)
- Incidence of Anti-drug Antibody (ADA)(14 weeks)
- Apparent Terminal Half-life (t1/2) of AVB-S6-500(12 weeks)
- Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)(12 weeks)
- Time of Maximum Observed AVB-S6-500 Concentration (Tmax)(12 weeks)
- Area Under Time-concentration Curve (AUC)(12 weeks)