Clinical Trials Logo
  1. Home
  2. End Stage Renal Disease
  3. NCT05285787

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05285787
Study type Interventional
Source Epizon Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 1, 2019
Completion date April 30, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02553889 - A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis Phase 2
Completed NCT01222234 - Impact of Vitamin D Therapies on Chronic Kidney Disease N/A
Recruiting NCT00243958 - Aluminum and Auditory Function in ESRD N/A
Active, not recruiting NCT03989141 - Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis. N/A
Completed NCT01526798 - Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis N/A
Completed NCT05769595 - Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) Phase 1
Completed NCT03119818 - Intracellular Phosphate Concentration Evolution During Hemodialysis by MR Spectroscopy N/A
Completed NCT01228279 - Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis Phase 4
Completed NCT02502903 - Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders Phase 1
Enrolling by invitation NCT06243900 - NIRS for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients
Completed NCT03358030 - A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis Phase 2
Recruiting NCT01415570 - Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) N/A
Completed NCT00548249 - Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis Phase 2