A Master Protocol for a Phase 1b Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 and REGN7508, Factor XI Monoclonal Antibodies, and REGN9533, a Factor XII Monoclonal Antibody, in Participants With End-Stage Kidney Disease on Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533.
The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option.
The main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533.
The study is looking at several other research questions, including:
- How much IMP is in the blood at different times and
- If the IMPs affect the ability of the blood to clot normally
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol
- •Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session
- •Has adequate vascular access
- •Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol
排除标准
- •Has history of major bleeding (International Society on Thrombosis and Haemostasis [ISTH]) criteria) within the past 3 months prior to the first screening visit as described in the protocol
- •Has known bleeding conditions (eg, Hemophilia A, B or C, von Willebrand's disease) hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
- •Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant [DOACs]) or dual antiplatelet therapy for clinical indication
- •Heart failure as classified by New York Heart Association (NYHA) class III or IV
- •Has a sustained uncontrolled hypertension as described in the protocol
- •Note: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
REGN9533
干预措施: Heparin (Drug)
REGN9933
干预措施: REGN9933 (Drug)
REGN9533
干预措施: REGN9533 (Drug)
REGN7508
干预措施: Heparin (Drug)
REGN9933
干预措施: Heparin (Drug)
REGN7508
干预措施: REGN7508 (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to approximately 78 days
Severity of TEAEs
时间窗: Up to approximately 78 days
次要结局
- Change in Prothrombin Time (PT)(From baseline up to approximately 78 days)
- Concentrations of REGN9933(Up to approximately 78 days)
- Concentrations of REGN7508(Up to approximately 78 days)
- Concentrations of REGN9533(Up to approximately 78 days)
- Change in activated Partial Thromboplastin Time (aPTT)(From baseline up to approximately 78 days)