EPN-701 for Calciphylaxis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the potential benefits of a new oral treatment, EPN-701, for individuals suffering from calciphylaxis, a rare condition that causes painful skin sores. It will assess EPN-701's effectiveness in alleviating symptoms and its safety for patients. The trial compares EPN-701 against a placebo (a pill with no active medicine) to evaluate its effectiveness. Individuals diagnosed with calciphylaxis, experiencing severe pain, and undergoing hemodialysis three times a week may be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like vitamin K-containing medications and warfarin, to participate in this trial. If you have already stopped warfarin due to calciphylaxis, you can be eligible for screening.
Is there any evidence suggesting that EPN-701 is likely to be safe for humans?
Research has shown that EPN-701, also known as menaquinone-7 or MK-7, was safe in earlier studies. Participants tolerated the drug well, with no serious side effects reported, indicating their bodies handled the treatment without major problems.
The safety results from these past trials suggest that EPN-701 might be a safe option for people with calciphylaxis, a condition with few treatment options. Although more research is needed to confirm its safety, these early findings are encouraging for those considering joining a clinical trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for calciphylaxis, which often involve sodium thiosulfate or surgical interventions, EPN-701 is administered orally, offering a potentially easier and more convenient option for patients. Researchers are particularly excited about EPN-701 because it introduces a new mechanism of action that targets the disease at a molecular level, potentially leading to more effective results. Additionally, the daily oral administration could improve patient compliance and overall quality of life compared to more invasive treatment methods.
What evidence suggests that EPN-701 might be an effective treatment for calciphylaxis?
Research has shown that low levels of Vitamin K2 can lead to small blood vessel calcification, a problem in conditions like calciphylaxis. In this trial, participants will receive either EPN-701 or a placebo. EPN-701, related to Vitamin K2, has shown promise in addressing these calcifications. Early studies on EPN-701 have focused on its safety, mechanism of action, and effects on skin and blood vessels. Although the findings are still preliminary, they suggest that EPN-701 might help reduce the painful skin sores seen in calciphylaxis by targeting the calcification process. This offers hope for its effectiveness in treating this serious condition.12346
Are You a Good Fit for This Trial?
This trial is for adults (18+) with calciphylaxis who have at least one painful skin ulcer and are on hemodialysis three times a week. Participants must agree to use effective birth control if they could become pregnant or have partners who could.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EPN-701 or placebo daily for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EPN-701
Trial Overview
The study tests EPN-701, an oral medication, against a placebo (salt water) in people with calciphylaxis. It aims to see if EPN-701 is safe and helpful for treating this condition. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
EPN-701 will be administered daily by mouth
Placebo will be taken daily by mouth
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sagar U. Nigwekar, MD, MMSc
Lead Sponsor
Epizon Pharma, Inc.
Collaborator
Citations
Study of EPN-701 for the Treatment of Calciphylaxis
Primary objective will be to determine the clinical efficacy and safety of EPN-701 in dialysis-dependent patients with calciphylaxis. The ...
Trial | NCT05285787
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 ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-clinical-trial-of-epizon-701-epn-701-in-subjects-with-end-stage-renal-disease-esrdA Clinical Trial of Epizon-701 (EPN-701) in Subjects With End ...
Decreased levels of Vitamin K2 are known to lead to microvascular calcification and are associated with dermatological and cardiovascular ...
EPN-701 for Calciphylaxis · Info for Participants
This trial is for adults (18+) with calciphylaxis who have at least one painful skin ulcer and are on hemodialysis three times a week.
Calciphylaxis in end-stage kidney disease: outcome data from ...
This UK wide study strengthens the evidence that calciphylaxis is a strong and independent risk factor associated with all-cause mortality.
epizon pharma, inc. confidential
The anticipated safety risks for EPN-701 are outlined in Section 6.3.4. Please refer to the. EPN-701 Investigator's Brochure for a complete ...
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