Study of EPN-701 for the Treatment of Calciphylaxis
ConditionCalciphylaxis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSagar U. Nigwekar, MD, MMSc
About this trial
Calciphylaxis is a rare but serious condition that leads to painful skin lesions. At present, there is no approved treatment for calciphylaxis. This research study is planned to examine the potential benefits of a new treatment (EPN-701) in patients with calciphylaxis. The present early clinical study will also evaluate the pharmacology of EPN-701 and whether it can be safely used in patients with calciphylaxis. Findings will inform the planning of a future definitive study to establish EPN-701 as an approved treatment for calciphylaxis.
Eligibility criteria
Qualifiers
Participant must provide written or electronic consent after the nature of the study has been explained, and prior to any research-related procedures, per the International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Clinical diagnosis of calciphylaxis confirmed by the Investigator with presence of at least one ulcerated skin lesion and moderate or severe pain (worst pain intensity in the preceding 24 hours of at least 5 on a 0-10 scale). Consistent with the clinical practice and expert recommendations, histological confirmation of calciphylaxis diagnosis by a skin biopsy is not a requirement for participation.
ESKD requiring thrice weekly hemodialysis
Male or female aged ≥18 years
Disqualifiers
In the opinion of the Investigator, presence of any clinically significant disease outside of calciphylaxis that may impact study participation and/or confound interpretation of the study results
Hospitalized at the time of Screening. Patients discharged from a hospital admission ≥24 hours prior to Screening may be eligible for participation.
Septic shock
Hospice or comfort care including withdrawal from dialysis
Trial design
Treatments tested in this trial
- EPN-701 (Oral)
- Placebo (Normal Saline)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sagar U. Nigwekar, MD, MMSc
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Epizon Pharma, Inc.
Collaborator
Source ClinicalTrials.gov