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

NCT05285787 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EPN-701-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Number of Participants with: Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths

  Through study completion; over 14 days treatment and one week follow up.

Secondary Outcomes (2)

• 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.

Other Outcomes (4)

• Change From Baseline to Day 15 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L).

  Day 1 to Day 15

• Change From Baseline to Day 22 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L).

  Day 1 to Day 22

• Mean Value of Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L) at Day 22.

  Day 22

Study Arms (1)

EPN-701, 10mg orally daily over 14 days

EXPERIMENTAL

Single arm

Drug: EPN-701 (Oral)

Interventions

EPN-701 (Oral) DRUG

MK-7

Also known as: menaquinone-7

EPN-701, 10mg orally daily over 14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Epizon Pharma, Inc.: lead

Study Sites (1)

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

menaquinone 7

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Rudy
• Organization: Epizon Pharma

jrudey@epizonpharma.com

2127551000

Study Officials

• Mark T Smith, MD

  Southeastern Clinical Research Institute, LLC 1521, Anthony Road Augusta, GA 30904

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)