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

End-Stage Renal Disease (ESRD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285787
• Other study ID #: EPN-701-001
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2022
• Source: Epizon Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End-Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• EPN-701 (Oral)
MK-7

Locations

Country	Name	City	State
United States	Southeastern Clinical Research Institute, LLC	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Epizon Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in circulating biomarker: Undercarboxylated Matrix Gla Protein (MGP), (pmol/L).	Undercarboxylated MGP (pmol/L).	Through study completion; over 14 days treatment and one week follow-up.
Primary	Adverse Events (AEs)	Frequency of treatment-emergent Adverse Events and treatment-emergent AEs assessed as related to the study drug.	Through study completion; over 14 days treatment and one week follow-up.
Secondary	Plasma concentrations of EPN-701.	• Maximum plasma concentration of EPN-701 (Cmax) [ng/mL].	Through study completion; over 14 days treatment and one week follow-up.
Secondary	Time to maximum plasma concentration of EPN-701.	Time to maximum plasma concentration of EPN-701 (Tmax) (h).	Through study completion; over 14 days treatment and one week follow-up.