Phase 2 Completed N=18 Treatment

A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)

End-Stage Renal Disease (ESRD)

Source: ClinicalTrials.gov NCT05285787 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Sep 2024

Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 8 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs)	8	—
SECONDARY Plasma Concentrations of EPN-701.	256	—
SECONDARY Time to Maximum Plasma Concentration of EPN-701.	5.83	—

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05285787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.