Study of EPN-701 for the Treatment of Calciphylaxis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Sagar U. Nigwekar, MD, MMSc
Study ID
NCT07583745
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Calciphylaxis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EPN-701 (Oral) — DRUG
    Randomized subjects will receive EPN-701 or placebo
  • Placebo (Normal Saline) — DRUG
    Randomized subjects will receive EPN-701 or placebo.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: EPN-701
    EPN-701 will be administered daily by mouth
  • Placebo Comparator: Placebo
    Placebo will be taken daily by mouth

Primary Outcome Measure

Change in pain intensity (Alternate Primary Endpoint) [ Time Frame: Baseline-24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Renal AssociatesBostonMassachusetts02114
Scott Krinsky
[email protected]
9784063408
[email protected]

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By research site
Renal Associates· Boston, MA

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