Study of EPN-701 for the Treatment of Calciphylaxis
NCT07583745 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-13
Summary
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.
Conditions
- Calciphylaxis
Interventions
- DRUG
-
EPN-701 (Oral)
Randomized subjects will receive EPN-701 or placebo
- DRUG
-
Placebo (Normal Saline)
Randomized subjects will receive EPN-701 or placebo.
Sponsors & Collaborators
-
Sagar U. Nigwekar, MD, MMSc
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2030-06-30
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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