A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)
Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
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.