NCT02437422已完成1 期
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients With End-Stage Renal Disease (ESRD)
Prolong Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年6月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion
研究概览
简要总结
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
详细描述
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
- •Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
- •Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
- •Hemoglobin >7.5 g/dL with or without clinical symptoms;
- •Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
- •Signed and dated informed written consent by the subject or his/her legally authorized representative;
排除标准
- •In the judgment of the investigator the patient is not a good candidate for the study;
- •Blood transfusion with in the last 90 days from date of Screening;
- •Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
- •Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
- •Concurrent or prior treatment within 90 days of Screening with an investigational medication;
- •Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening;
- •Evidence or history of regular alcohol abuse;
- •Screening laboratory result(s) determined to be clinically significant by the investigator;
- •Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency;
- •Screening laboratory result or laboratory results performed within one year indicating positivity for hepatitis B surface antigens, hepatitis B core antibodies, or hepatitis C antibodies;
- •Uncontrolled Diabetes Mellitus (Patients with HbA1c > 9% at screening)
研究组 & 干预措施
SANGUINATE
Experimental
Single infusion of SANGUINATE
干预措施: SANGUINATE (Biological)
结局指标
主要结局
Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion
时间窗: 90 days
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
次要结局
- Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays(90 days)
- Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays(90 days)
- Mean change in the calculated panel reactive antibody (CPRA)(90 days)
- Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays(90 Days)
- Percent of patients with an increase in CPRA(90 Days)
- Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)(22 Days)
- Percent of patients with an increase in the overall strength of HLA-Antibodies(90 Days)
研究者
研究点 (2)
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