A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)
- Conditions
- End-Stage Renal Disease (ESRD)
- Interventions
- Drug: EPN-701 (Oral)
- Registration Number
- NCT05285787
- Lead Sponsor
- Epizon Pharma, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EPN-701, 10mg orally daily over 14 days EPN-701 (Oral) Single arm
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) 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
- Secondary Outcome Measures
Name Time Method Plasma Concentrations of EPN-701. Through study completion; over 14 days treatment and one week follow-up. • Maximum plasma concentration of EPN-701 (Cmax) \[ng/mL\].
Time to Maximum Plasma Concentration of EPN-701. Through study completion; over 14 days treatment and one week follow-up. Time to maximum plasma concentration of EPN-701 (Tmax) (h).
Trial Locations
- Locations (1)
Southeastern Clinical Research Institute, LLC
🇺🇸Augusta, Georgia, United States