A Phase 2 Prospective Safety/Tolerability, Pharmacokinetics, Surrogate Biomarkers as Proxies for Efficacy Trial of EPN-701 in Subjects With Stable End Stage Renal Disease (ESRD) Receiving Outpatient Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
Patients with End Stage Renal Disease (ESRD) are prone to early and accelerated vascular calcification. Both the prevalence and extent of the vascular calcification are predictive for cardiovascular morbidity and all-cause mortality in this population. There is a growing body of evidence suggesting that dialysis patients have a primary, functional deficiency of Vitamin K2 as evidenced by reduced levels of circulating biomarkers including carboxylated forms of Matrix Gla Protein (MGP), Osteocalcin, and Fetuin-A, which are important inhibitors of vascular calcification. Decreased levels of Vitamin K2 are known to lead to microvascular calcification and are associated with dermatological and cardiovascular conditions such as calciphylaxis and peripheral arterial disease (PAD).
The purpose of this Phase 2 study is to examine the safety and pharmacokinetics of EPN-701 (menaquinone-7; MK-7) and to assess the effects on certain circulating biomarkers when MK-7 is orally administered once daily for 14 days.
详细描述
Patients with End Stage Renal Disease (ESRD) are prone to early and accelerated vascular calcification. Both the prevalence and extent of the vascular calcification are predictive for cardiovascular morbidity and all-cause mortality in this population. There is a growing body of evidence suggesting that dialysis patients have a primary, functional deficiency of Vitamin K2 as evidenced by reduced levels of circulating biomarkers including carboxylated forms of Matrix Gla Protein (MGP), Osteocalcin, and Fetuin-A, which are important inhibitors of vascular calcification. Decreased levels of Vitamin K2 are known to lead to microvascular calcification and are associated with dermatological and cardiovascular conditions such as calciphylaxis and peripheral arterial disease (PAD). The purpose of this Phase 2 study is to examine the safety and pharmacokinetics of EPN-701 (menaquinone-7; MK-7) and to assess the effects on certain circulating biomarkers when MK-7 is orally administered once daily for 14 days.
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
- •Consenting subjects.
- •Adult male and female who were diagnosed with stable ESRD.
- •Subjects treated with maintenance hemodialysis at least 3 times a week for at least 3 months prior to the first dose of study drug.
- •Clinically stable.
排除标准
- •Solid organ transplant.
- •Malignancy.
- •Severe infection requiring intravenous (IV) antibiotics.
- •Any co-existing disease or condition that could have compromised the safety of study participants and/or the integrity of the study.
研究组 & 干预措施
EPN-701, 10mg orally daily over 14 days
Single arm
干预措施: EPN-701 (Oral) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Through study completion; over 14 days treatment and one week follow up.
Number of Participants with: Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths
次要结局
- Plasma Concentrations of EPN-701.(Through study completion; over 14 days treatment and one week follow-up.)
- Time to Maximum Plasma Concentration of EPN-701.(Through study completion; over 14 days treatment and one week follow-up.)