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NCT05285787 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)
A Phase 2 study of End Stage Renal Disease (ESRD), sponsored by Epizon Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05285787: Completed Phase 2 study of End Stage Renal Disease (ESRD), sponsored by Epizon Pharma.
NCT05285787 is a Phase 2 study of End Stage Renal Disease (ESRD) that has completed, run by Epizon Pharma. The registered enrollment target is 18 participants, below the 374-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05285787, a Phase 2 study of End Stage Renal Disease (ESRD), has completed, sponsored by Epizon Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of Participants with: Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths
Conditions Studied
Interventions
- DRUG EPN-701 (Oral)
Study Locations (1)
Georgia
- Southeastern Clinical Research Institute, LLC - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2021-04-30 |
| Phase | Phase 2 |
What the finished NCT05285787 record still lists
NCT05285787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 374-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (95% lower).
The record links to 1 condition, with End Stage Renal Disease (ESRD) appearing as the primary indexed condition, and to 1 intervention - of which EPN-701 (Oral) is the first listed.
NCT05285787 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05285787 about?
NCT05285787 is a clinical study titled "A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)". 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 ...
What is the current status of trial NCT05285787?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-03-01. Estimated completion is 2021-04-30.
What conditions does trial NCT05285787 study?
This clinical trial studies the following conditions: End Stage Renal Disease (ESRD).
What interventions are being tested in trial NCT05285787?
The interventions under investigation include: EPN-701 (Oral) (DRUG).
Who is sponsoring clinical trial NCT05285787?
This trial is sponsored by Epizon Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05285787 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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