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ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

Study acronym: SPARVASC
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Aug 18, 2025, no change to tracked fieldsv5-v6
  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 40 to confirmed 32 · Primary completion date changed from estimate of Dec 1, 2024 to Jul 18, 2024 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 40 to confirmed 32
    • Primary completion date changed from estimate of Dec 1, 2024 to Jul 18, 2024
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Start date changed from estimate of Dec 1, 2022 to Dec 8, 2022v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
ANCA-associated vasculitis is an autoimmune disease that causes damage to blood vessels. This leads to organ damage with the number of organs affected and the severity of damage varying significantly between patients. Vasculitis patients also have a very high risk of heart attacks and strokes, called cardiovascular disease. A chemical called 'endothelin', produced by the blood vessels, causes vessels to stiffen and raises blood pressure and this associates with cardiovascular risk. The investigators have previously shown that by blocking the effects of endothelin you reduce vessel stiffness, lower blood pressure and improve vessel function. However, these studies only blocked endothelin for a few hours. Now, the investigators would like to see if it is possible to maintain these benefits by blocking endothelin for longer. Sparsentan is a tablet that blocks endothelin and lowers blood pressure. The investigators plan to give sparsentan to patients with vasculitis for 6 weeks. To determine if any beneficial effects of sparsentan are due to blood pressure lowering the investigators will give another group of vasculitis patients a tablet called irbesartan which lowers blood pressure but does not block endothelin. The investigators will compare the results between the two groups.
Trial Details
NCT Number NCT05630612
Lead Sponsor University of Edinburgh
Collaborators: Travere Therapeutics, Inc.
Conditions ANCA Associated Vasculitis, Cardiovascular Diseases, Kidney Diseases
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov